CURRENT NATIONWIDE OPPORTUNITIES AS OF 7/15/15

New Jobs Released Since Last Update are in Blue Text

If a job in which you are interested does not appear below, please contact me to request the job description.

EXCEPT AS OTHERWISE NOTED, positions are on-site and full time:- Client is offering relocation assistance.- MUST EITHER be a U.S. Citizen or Green Card Holder and MUST be a CURRENT US resident.- No Third-party recruiters, please.

SOUTHWESTERN US OR AZ 1 Quality Engineer (Medical Devices) 2 Regulatory Affairs Analyst/ Specialist II (Medical Devices) 1 Sr R&D Eng. up to $80-$90K plus bonus 1 Quality Engineer II – Controls Sr. Product Manager (medical Devices) up to $85K-$90K plus bonus, possibly more for

exceptional candidatesCA

1 Lead Software Developer or Manager (Cakephp and Lamp development experience a must), North County, San Diego, base up to $80-110K or possibly higher (no relocation offered. Awaiting Job description )

IL or Midwest 2 New Product Development Mechanical Eng.(Medical Devices: Spine) 2 Sr. Product Development () Mechanical Eng.(Medical Devices: Spine) 1 Quality Engineer (Medical Device: Spine or Ortho) 1 Project Eng., Polymer/Plastic/Thermoplastic) - $75K - $85K, possibly up to $100K for the right candidate 1 VP, Engineering (Medical Devices-Spine) Mechanical Eng., (No job description available) 1 Director of Marketing, Wound Care up to $160K plus bonus 1 Global Product Manager (Urology) up to $130K plus bonus (No relocation Offered) 1 Global Marketing Manager (Urology) up to $150K plus bonus (No relocation offered. PENDING OFFER) 1 Downstream Marketing Manager, SS (Consumer Medical Products)

IN 1 Automation Process Engineering Lead, Indiana up to $80-110K base, IN 1 EH& S Manager – IN up to $100-120K base, IN

MN 1 Director, Software Engineering (Medical Device) - $150K - $200K plus 40% bonus potential 1 Applications Software Manager (Medical Device) – $105K-$140K plus bonus potential

NJ 1 DIRECTOR, INTERNATIONAL REGULATORY AFFAIRS / QUALITY (MEDICAL DEVICES) - NJ

(Experience with Japan Regulatory Environment) – ON HOLDOK

1 Mining Engineer up to $80-90K, OKSC

1 Senior Process Engineer (Product Technologies) up to $80-100K plus 10 % bonus target, SC

TN

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1 Sr. Industrial Engineer– 75-85k (20%) –MUST have Time Study and Labor Management System experience

TX 1 Superintendent of Mining - 2 locations in TX - $68K - $75K, possibly up to $80K

Southwestern US or UT 2 Quality Engineers (Medical Devices: One is Senior) 1 Regulatory Affairs Analyst/ Specialist II (Medical Devices) 1 Director, Quality Engineering (Medical Devices Manufacturing) up to $170K plus bonus Project R &D Engineer, Medical Devices, UT 2 Product R&D-New Product Development, Mechanical Engineers (Medical Devices) 1 Sr. Engineer up to $100K-$105K plus bonus (Medical Devices) 1 Principal Quality Eng. (Design Control/Assurance and Injection Molding) – Low $100Ks or

possibly as high as $120K plus bonus potential, (Medical Devices) 1 Principal Validation Eng. Up to $95K plus bonus potential, (Medical Devices) 1 Director, Product Development (Medical Devices Engineering) up to $180K plus bonus 1 Program Manager (Medical Devices) up to $130K plus bonus 1 Integration Project Manager (Medical Devices) 1 Integration Project Manager (M&A: Medical Devices) 1 Group Director, Regulatory Affairs/Quality Affairs (Medical Devices) 1 Regulatory Affairs Compliance Manager (Medical Devices) 1 Quality Engineer – Type 1 (Medical Device) 1 Quality Engineer – Type 2 (Medical Device) 1 Project Manager (Medical Device) up to $115K plus bonus 1 Product Manager I or II (Medical Device) $80-$97K or up to $116K based on Prod. Mgr. Level

Southern UT 1 Junior Accountant, (Job description pending), Southern UT 1 CPA Staff Manager, (Job description pending), Southern UT

BELOW ARE JOB DESCRIPTIONS FOR OUR OPENINGS. If you do not see a particular listing, please request it.

SOUTHWESTERN US OR ARIZONA

SR. PRODUCT MANAGER - MEDICAL DEVICES - SOUTHWESTERN US

SUMMARYThe Senior Product Manager plans, directs and coordinates all marketing related efforts of specific product lines. Responsible for upstream marketing activities for designated products including strategy and new product development. Develops global marketing plans, strategies and tactics; then works with both U.S. and international counterparts to ensure effective implementation and follow-up. Has strong collaboration and leadership skills to effectively manage cross-functional initiatives. Must have a very hands-on approach to the business and be highly accountable for results. Will develop excellent, in-depth knowledge of the company products and programs and achieve an appropriate level of clinical knowledge to be viewed as a

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resource by our customers, our sales team, and internal employees. The Senior Product Manager may also be given direct report management responsibilities.Essential Job Functions:

Conducts market research as necessary to gather design input, market trends, competitive activity, customer perspectives, etc

Work closely with R&D for the timely development and release of product line extensions, product platforms, and enabling new product technologies.  Lead translation of market needs to design features.

Identify new markets through various methodologies. Develops and manages product line marketing budgets within overall operating budgets Works with US and international counterparts to prepare and execute detailed new product

launch plans, which include positioning, clinical data, selling tactics, forecasting, pricing, reimbursement, promotional programs, press releases, sales training, physician training, etc.

Create promotional materials, marketing programs, and sales tools. Determine product prices that support product line profitability. Evaluate product line expansion/pruning based on sales and profitability and implement

appropriate change orders and field communications. Develop annual product sales forecast based on procedure strategies, adoption rates, delivery

alternatives, and corporate objectives. Work with professional education and sales training to create key customer visits and labs. 

Conduct new product training and sales force training. Support field sales organization on highly technical product inquiries; provide appropriate

product information to field sales organization, including technical data and product availability information.

Perform other duties as assigned by supervisor 

Basic Qualifications:

Excellent presentation, organizational and interpersonal skills required Extensive knowledge of medical device industry and company products Ability to prepare and deliver presentations to the management team and board of directors Product life cycle management experience Product profitability management Forecasting and pricing experience Demonstrated development of promotional materials Demonstrated leadership, communication, teamwork, and organizational skills Ability to think and act strategically Travel Required 25%-50% Additional Desirable Qualifications Skills and Knowledge: Demonstrated ability to build and maintain strong relationships with KOLs Demonstrated ability to think creatively Strong analytical and technical skills Good business judgment and maturity

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Senior Quality Engineer - Southwestern US

This position develops, implements and improves new and existing product quality requirements.Essential Job Functions:1. Provide Quality Engineering representation on Product Development Teams.2. Initiate new or revised documentation3. Lead cross-functional teams to develop risk assessment.4. Develop physical and functional test methods to ensure specifications are met.5. Write, review and approve design verification and validation protocols and reports.6. Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.7. Conduct and /or coordinate testing outlined in protocols and test methods.8. Perform process improvement, control and monitoring on manufacturing processes.9. Provide technical direction during design transfer activities.10. Conduct complaint investigations.11. Participate and provides input to training on department/division procedures, and policies.12. Participate in project planning, budgeting, scheduling and tracking.13. Coordinate and lead internal and supplier audits.14. Develop and implement procedures to comply with corporate and industry standards.15. Understand and follow company procedures on regulatory requirements.16. Provide support to the regulatory department in writing technical submissions.17. Provide positive example and actively promotes compliance to all standards.18. Maintain a professional working relationship with internal and external customer and support staff.19. Prepare and present project updates and technical discussions.           Basic Qualifications:Ability to make and present engineering decisions2. Strong interpersonal skills3. Demonstrated Project Management skills4. Advanced statistics4.1. Understanding and application of DOE 5. Ability to lead cross functional teams6. Engineering cost analysis7. Ability to analyze and optimize manufacturing and quality systems8. Advanced product, design & prototyping skills9. Ability to create and provide training10. Software application skills11. Advanced problem solving skills12. Ability to create, review and coordinate test protocols and reports13. Ability to generate engineering proposals14. Oral and written presentation skills15. In-depth knowledge of regulatory requirements16. Ability to develop and control a budget17. Ability to manage technical personnel18. Ability to perform design review functions19.Must read, write and understand English. Must be detailed in handling information/data.Additional Desirable Qualifications Skills and Knowledge:Prefer a minimum of 6 year’s experience in the medical field or closely related industry or a Master’s Degree plus three years.Education and/or Experience:A minimum of a Bachelor’s degree in Engineering.Prefer a minimum of 6 year’s experience in the medical field or closely related industry or a Master’s Degree plus three years.Quality Engineering Certification (ASQ) or equivalent. 

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Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.

QUALITY ENGINEER II - CONTROLS - (Medical Device)

This position is responsible for conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, test methods and equipment.

Summary of Position with General Responsibilities: Responsible for systems assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Will support Manufacturing, New Product Development, and Regulatory to ensure systems are in compliance with all internal and external guidelines.

Essential Job Functions: The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position. Scope·Consultant/ Department expert·Technical Expertise·Organizational credibility and knowledge·Guides and Develops Others·Influences and directs others within Department·Results Oriented·Project Leader·Business Knowledge Potential Task Assignments within the scope of this position1.Initiates new or revised documentation and tracks through appropriate approval cycles and implementation2.Maintains a professional working relationship with internal & external customer and support staff3.Participates and/or leads cross-functional teams.4.Provides technical support on components, material methods, systems and equipment.5.Develops physical and functional test requirements to assure specifications & regulations are met.6.Writes and approves protocols, reports and data.7.Oversees testing outlined in protocols and test methods8.Coordinates/develops validation studies on equipment & processes9.Executes design controls10.Analyzes design inputs11.Conducts complaints investigations12.Understands and follows company procedures and regulatory requirements.13.Participates in and provides input to training on department & division procedures, and policies.14.Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling and tracking.15.Plans and coordinates engineering test builds.

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16.Analyzes problems in design, process and test development. Recommend solutions.17.Prepares and presents oral and written project updates and technical discussions.18.Develops and implements procedures to provide easy-to-follow instructions.

Basic Qualifications: This position requires: • a Bachelor degree in science or engineering with 4 (four) year of engineering experience within the medical device or equivalent regulated industry OR• Masters degree with 3 (three) years of engineering experience within the medical device or equivalent regulated industry

The above experience must include demonstrated effective project management skills.

The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities.Additional Desirable Qualifications Skills and Knowledge: 1.Ability to make and present engineering decisions2.Strong interpersonal skills3.Ability to systematically manage multiple projects from initiation through closing phases. Projects include client and/or supplier resourced deliverables:o Determine and communicate project deliverableso Develop a work breakdown structure and estimateso Develop a viable schedule, management plans, and scheduleo Execute and control the project through closure4.Specific specialized engineering skills such as:o Create & critique engineering cost analysiso Basic tooling design and drafting knowledgeo Analyze and optimize existing process and ability to create new processeso Create, analyze and optimize manufacturing and quality systemso Basic product, design & prototypingo Material Scienceo Bioengineering principles5.Ability to train, create and critique training6.Ability to apply comparative statistics7.Software application skills8.Problem solving ability9.Ability to create, review and coordinate test protocols and reports10.Ability to generate engineering proposals11.Oral and written presentation skills12.Ability to lead cross functional teams13.Understanding of regulatory environment14.Demonstrated ability to create and execute project plans15.Demonstrated Supervisory skills16.Ability to create and control a budget

Senior R&D Engineer - Southwestern US

Essential Job Functions:

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1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation

2. Maintains a professional working relationship with internal & external customer and support staff3. Participates and leads cross-functional teams.4. Provides technical support on components, material methods, systems and equipment.5. Develops physical and functional test requirements to assure specifications & regulations are met.6. Writes and approves protocols, reports and data.7. Manages testing outlined in protocols and test methods8. Manages/develops validation studies on equipment & processes9. Conducts complaints investigations10. Executes design controls11. Participate in collecting/developing and analyzing design inputs12. Understands and follows company procedures and regulatory requirements.13. Participates in and provides input to training on department & division procedures, and policies.14. Manages project planning, budgeting, scheduling and tracking.15. Plans and coordinates engineering test builds.16. Analyzes problems in design, process and test development. Recommend/implement solutions.17. Prepares and presents oral and written project updates and technical discussions.18. Develops and implements procedures/policy.

Basic Qualifications:1. Experience as the lead R&D engineer on a medical device product development program2. Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development3. Design capability with small plastic and metal parts4. Demonstrated proficiency with Geometric Dimensioning and Tolerancing (GD & T)5. Working knowledge of nitinol and other materials typically used in medical devices6. Significant experience in product verification and validation testing, medical device new product development and rapid prototyping.7. Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage).8. Clinical trial and/or animal trial experience9. Proficient in technical writing of protocols and reports. 10. Proven capability in writing clear and detailed testing and product assembly procedures. 11. Impeccable documentation skills and adherence to design control procedures and GLP12. Demonstrated experience in application of lean manufacturing principles.13. Comfortable in a dynamic working environment with a high amount of change 14. Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Taguchi Design of Experiments) 15. Familiarity with Pro-E and/or FEA software16. Ability to make and present engineering decisions.

Education and/or Experience:

Bachelor degree in science or engineering with 6 (six) years of engineering experience within the medical device or equivalent regulated industry OR

Master’s degree with 5 (five) years of engineering experience within the medical device or equivalent regulated industry

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The above experience must include 3 (three) years’ proven and effective project management skills.

ILLINOIS OR MIDWEST

PRODUCT DEVELOPMENT ENGINEER: MEDICAL DEVICES – SPINE, MIDWEST

PRIMARY FUNCTIONS & RESPONSIBILITIES:Under limited guidance, will perform highly complex engineering duties associated with the design and development of spine implant and instrument systems.Responsible for different research & development activities that could involve multiple interfaces internal and external to the company.Interface with surgeons to develop user requirements and evaluate designs.Review and approve both implant and instrument designs and drawings.Control and implementation of Product Development process, including Project Planning, FMEAs, Design Reviews, DHF creation & maintenance, etc.Research, analyze and create intellectual property.Interface with various vendors to manufacture prototypes and finished devices.EXPERIENCE & SKILL REQUIREMENTS:Must have proven comprehensive experience in spine instrumentation product development.Should have working understanding of FDA QSR, MDD and ISO-13485 principles.Should be a self-motivated individual that is able to work with limited supervision.Ability to conduct theoretical analysis and develop mechanical test protocols of different spine implant types.Commanding knowledge of 3D CAD systems (SolidWorks preferred).Working knowledge of manufacturing processes and capabilities.

EDUCATIONAL REQUIREMENTS:One of the following:

B.S. Mechanical Engineering and at least 7 years’ experience including minimum of 5 years spine instrumentation development experience.M.S. Mechanical Engineering and at least 5 years’ experience including minimum 3 years spine instrumentation development experience.

SR. PRODUCT ENGINEER: MEDICAL DEVICES – SPINE, MIDWEST

PRIMARY FUNCTIONS & RESPONSIBILITIES:Lead a cross-functional project team (including both internal and external team members such as spine surgeons) of several new development projects.Direct participation in implants & instruments concept generation and design.Maintain and improve existing products and processes.Provide hands-on design, engineering, and analysis direction to other R&D engineers.Participate in establishing company and product strategy.

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Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, and inspection requirements and manufacturing process requirements.Provide engineering support to customer service, sales, marketing, regulatory and quality.Assure timely and effective project completion according to the project plan and budget.Review engineering designs for feasibility and accuracy.Approve engineering drawings and specifications.Complete and approve all Design History File documentation for assigned projects as required.Identify, analyze and recommend new technologies or materials for specific product applications.Participate in patent application preparation, patent review and patent analysis.Establish, develop and maintain strong working relationships with all necessary personnel to ensure smooth product design, development and commercialization.Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).Assist in the resolution of manufacturing- or quality-related issues.Know and apply elements of the Quality System and medical device-related Federal and International standards.

EXPERIENCE & SKILL REQUIREMENTS:Should have comprehensive experience in all phases of spine instrumentation products development.Must have a solid understanding of FDA QSR, MDD and ISO-13485 principlesMust have practical working knowledge of anatomy and physiology, especially as related to the spine, spine biomechanics, spine disorders, fundamentals of spine fusion and non-fusion surgery, mechanical test and measurement techniques and methods, manufacturing & inspection methods and processes, FDA and ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.Must have excellent communication (verbal & written) and organizational skills. Must have demonstrated ability to work effectively in a team environment.

Must be creative and have the ability to independently apply theoretical technical principles to product design.Must have the ability to apply parametric solid modeling and drafting conventions to design projects.Must have commanding knowledge of various software packages including Microsoft Office applications, CAD applications (SolidWorks a definite plus) and Engineering Simulation applications (ANSYS or similar). Must have the ability to prioritize and manage several projects simultaneously.

EDUCATIONAL REQUIREMENTS:One of the following:

B.S. Mechanical or Biomedical Engineering and at least 10 years’ experience including minimum 7 years spine instrumentation development experience.

M.S. Mechanical or Biomedical Engineering and at least 7 years’ experience including minimum 5 years spine instrumentation development experience.

DOWNSTREAM MARKETING PRODUCT MANAGER, SS (CONSUMER MEDICAL PRODUCTS) - Midwest

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Client’s product is uniquely designed to support people with an ostomy or bladder management needs. It is strategically important to both the Ostomy and Continence Care business strategies as a means to interact closely with consumers with the intent to drive satisfaction with company. The Marketing Manager will be responsible for developing the overall marketing strategy, as well as designing, developing and executing brand guidelines, positioning, messaging and supporting tools for product coordinators, field sales. This position will also manage strategy and content for this product’s website and all other consumer-directed marketing. This position will need to closely collaborate with product line marketing managers and product-specific managers.

RESPONSIBILITIES

Marketing Strategy Formulation

Develop short, medium and long-term marketing strategy in alignment with overall strategy Translate marketing strategy into well-thought out annual marketing plans Understand market, customer and competitive trends and factor into marketing strategy

Develop, Execute, and Monitor for Consistency of the Brand Guidelines and Positioning (in alignment with overall Strategy)

Continue to review/enhance existing brand guidelines Liaise with Corporate Communications and Global Marketing to ensure alignment to corporate

and global guidelines Liaise with Business Unit marketing to ensure alignment with Business Unit strategy and

positioning Ensure all marketing collateral and communication vehicles adhere to the brand guidelines and

positioning In collaboration with product-specific Managers and Business Unit sales and marketing

management, develop process for ongoing monitoring of messaging consistency and correct usage of marketing collateral

Healthcare Facility Setting: Design, Develop, and Implement Marketing Strategy, Messaging and Associated Tools for Coordinators, Field Sales, and Health System KAMs across Ostomy and Continence Care

Develop an annual marketing plan for this audience Co-travel and attend key customer events to stay current on customer needs Develop briefs for each marketing piece and effectively communicate scope and approach to

agency Project manage agency to ensure timely delivery of high-quality deliverables

Coordinate with Business Unit marketing to gather feedback from all relevant stakeholders on marketing promotion and/or new service enhancements required

Manage pink sheet process with support from marketing coordinator Lead the development and execution of the product’s portion (within Business Unit section) of

sales meetings, including conducting training as needed

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Lead the development and execution of conference booth strategy for product section, in coordination with Business Unit Marketing

Community Setting: Design, Develop, and Implement Marketing Strategy, Messaging and Associated Communication Vehicles Targeted Directly at Ostomy and Continence Care Consumers

Develop an annual marketing plan for this audience Regularly listen in on consumer calls, attend consumer association and/or support group events,

and company-sponsored patient panels to stay current on customer needs Develop briefs for each marketing piece and effectively communicate scope and approach to

agency Project-manage agency to ensure timely delivery of high-quality deliverables Coordinate with Business Unit marketing to gather feedback from all relevant stakeholders on

marketing promotion and/or new service enhancements required Manage materials approval process with support from marketing coordinator Lead the development and execution of product portion of consumer events in coordination

with Business Unit Marketing Act as website manager, ensuring content is current, consistent and relevant to our customers

Coordinate and Collaborate with internal stakeholders to ensure full alignment

Coordinate/collaborate with U.S. Ostomy and Continence Care Marketing teams to ensure services’ messaging is in alignment with overall business strategy, and that product element of the overall business unit portfolio strategy is well understood by Field Sales

Solicit Business Unit sales and marketing management input on what specific marketing programs and tools are required to best support the BU Sales and Marketing Plan

Ensure tight alignment during Annual Operating Plan (AOP) and Mid-Year Review (MYR) planning

Participate in Business Unit marketing team meetings as needed Coordinate/collaborate with Ostomy and Continence Care managers to ensure that what is

marketed can be executed. Solicit their input on what marketing programs and tools are required by various internal stakeholders. Provide input to them regarding new service enhancements that may be required

Liaise with Compliance on development of all written messaging, tools, etc. Keep Business Unit Ostomy/Continence Care Leadership and Global Marketing up-to-date on

strategies and tactics

Miscellaneous

Manage operating expense budget, including presenting at annual budget meetings Keep up-to-date on Global Marketing best practices and marketing plan templates Attend internal Marketing training programs Participate in monthly product leadership team meetings and provide input on Development

Succession Review (DSR), team-building and resolution of product organization-wide issues and/or opportunities

All other projects as assigned

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QUALIFICATIONS

Academic/Credentials/Certifications

BS/BA degree MBA preferred

Length of experience

8-12 years of marketing or marketing communications experience (ideally in consumer industry)

At least 3 years of experience in a consumer-based, regulated industry

Specialized skills/technical knowledge

Experience in developing innovative strategies and driving the execution of the strategies Demonstrated quantitative analysis skills. Strong verbal and written communication skills Strong cross-functional relationship management skills Proven track record of delivering results; self-starter Strong business acumen/thinking sills Sr. Management presentation/interaction skills Basic computer knowledge (e.g., Microsoft office) Experience with CRM systems and/or SF.com Experience with website management (optional) Marketing Communications/Advertising Agency experience (optional)

DIRECTOR, MARKETING, WOUND CARE - MIDWEST

The Director, Marketing, Wound Care is responsible for building a global wound care product portfolio and the wound care business strategy to achieve accelerated and profitable growth. This includes defining clear positioning, pricing, promotion plans, product portfolio decisions and channel strategies for the product line in order to optimize overall revenue and profit globally. This individual will work directly with country management, sales & marketing management and have significant customer interaction. The role is 80% focused on US initiatives and 20% on defining Global strategies.

RESPONSIBILITIES

Build a global Wound Care Product Portfolio

Partner with the Global R&D and Corporate Development functions to identify, license and acquire from the outside new products to fulfill the global product and marketing strategy.

Define and develop a comprehensive and profitable portfolio of products to position company as a major player in the Wound Care market, first in the US and then globally.

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Drive product development to optimize the product portfolio through strategic relationships and partnerships.

Lead/participate as part of an acquisition team to identify potential license and acquisitions, conduct due diligence on potential portfolio additions and develop integration strategies.

Anticipate and identify industry, reimbursement and competitor trends and utilize as inputs for product and program development. Create strategies and tactics to compete against current and future competitive threats.

Provide leadership, direction and management to the marketing team and new product development resources.

Work closely with operations to understand and sponsor capital expenditure projects (timing, size, scope, technology, location, etc.) to ensure stable inventory levels for the growing business

Develop and execute the Wound Care business, product and service strategy.

Develop, define and implement the strategy for the wound care business which includes brand strategy, product portfolio and product positioning in order to achieve accelerated sales growth. Prioritizing the growth in the US to demonstrate sustainability.    

Drive a global and local understanding of market needs relative to internal and external capabilities, and execute investment strategies to maximize value for profitable growth.

Ensure that effective market analysis is conducted in all regions as input to the global strategy development.

Create and execute marketing strategies; ensure best practices are leveraged in local markets according to unique needs.

Lead the Marketing Team for Wound Care with a particular focus on associate capability building and development

Build the capabilities of all marketing team members in order to build a strong bench of talent for both global marketing organization and country/local marketing teams.

Provide strategic direction to US Product Managers Proactively manage all performance expectations and assessments for the team; conduct annual

career development sessions and develop/succession planning activities for the team

QUALIFICATIONS

Academic Qualifications

Bachelor’s degree in Business, Marketing, or Healthcare MBA strongly preferred

Length of Experience

15+ years of overall marketing experience, wound care experience is strongly preferred

Specialized/Technical Skills

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Strong strategic marketing skills including experience in the development of portfolio strategy, marketing plans and branding/marketing campaigns

Experience managing people and technical resources in a direct and matrix capacity Excellent communication skills Strong relationship management skills; proven track record of producing results in a matrix

GLOBAL MARKETING, Urology – IL (No relocation offered. PENDING OFFER)

The Global Marketing Manager will be responsible for identifying and executing strategies to profitably grow Continence Care (CC) product sales globally. This position will create, implement and execute on marketing/brand plans and new product launches in accordance with the overall CC corporate strategy.

This position will interact regularly with the country business units who commercialize these products to ensure coordination of plans and alignment of global and local strategy. Additionally, this position will provide internal direction to other functional areas including R&D, Operations, Clinical Research and Manufacturing regarding overall business strategy, customer requirements, product features/benefits, positioning/promotion, and business unit requests/needs. Will be required to lead and work closely with the Global Marketing Insights and Analytics, Health Economics, and Clinical Education teams to build comprehensive strategies for new product launches and sales/profit growth.

RESPONSIBILTIESBrand Strategy•Contribute to development of a global marketing/brand plan •Lead the execution of global initiatives and strategies defined in the marketing/brand plan New Product Commercialization•Drive NPC (New Product Commercialization) projects through company’s defined launch process •Define additional product portfolio needs and drive programs to fill gaps. Identify and prioritize new products •Manage market input/feedback and translate into true market needs and product features •Develop and update global launch plans throughout launch stage-gate process in order to justify advancement of the project •Manage forecasting (7-year and launch forecasts) for new products with local BUs and Corporate Finance in order to build solid financial decision making platform •Lead the creation of strong product positioning, including development of marketing claims for new products •Manage development of global marketing campaigns for new product launches (together with ad agency) •Support local BUs in developing local new product launch plans through the “GO2 Market” process •Monitor and report product launch progress (as part of post launch review plan) Business Unit Partnership

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•Work collaboratively with multiple levels of business unit teams (local marketing, country managers, regional VPs) to define and implement local strategies •Provide day-to-day leadership and integration to the BU's and functional groups to ensure effective and consistent execution of agreed-to marketing strategies and plans •Gain market insights and translate into business/portfolio needs •Work with business units to capture data on product opportunities, monitor new product launches and movement, meet forecast numbers, and monitor revenue performance Perform Other Duties as RequiredAct as the voice of the customer in cross-functional business, project, and strategic decision making ESSENTIAL FUNCTIONS OF THE ROLEAbility to travel up to 30% of the time.QUALIFICATIONS Academic Qualifications•Bachelor’s in Business, marketing, healthcare, or a technical discipline required •MBA or equivalent degree highly preferred Experience•At least 10 years of experience in marketing, preferably in medical device or healthcare industry •Direct experience launching new products is required Specialized Skills/Other•Strong relationship management and communications skills required •Project management experience required •Healthcare and/or medical device experience required •Product launch experience required •Robust analytical ability and understanding of forecasting process required •Strong understanding of healthcare/medical devices environment required •Solid understanding of healthcare reimbursement policies and potential impact on company strategy •Team leadership experience preferred •Experience developing and executing marketing plans/campaigns preferred •Candidate must be local to IL

GLOBAL PRODUCT MANAGER, Urology – IL (No relocation offered)

The Global Product Manager will manage and execute new product commercialization projects in close cooperation with cross-functional project teams and country-level marketing teams. This position will create, implement and execute on marketing plans and product launches in accordance with the overall brand strategy. Requires strong partnership with local marketing teams to define and translate global marketing strategies into local initiatives.

RESPONSIBILTIESProject Management

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• Drive NPC (New Product Commercialization) projects through company launch process• Support Front End Innovation (FEI) stages with FEI Manager and NPPD stages (Gate 2-) with Core Team Leader• Manage market input/feedback and translate into true market needs and product features• Develop and update global launch plans throughout stage-gate process in order to justify advancement of the project• Manage forecasting (7-year and launch forecasts) for new products with local BUs and Corporate Finance in order to build solid financial decision making platform• Contribute to development of a global marketing/brand plan• Manage development of global marketing campaigns for new product launches (together with ad agency)• Support local BUs in developing local new product launch plans through the “GO2 Market” process• Monitor and report product launch progress (as part of post launch review plan)Product Strategy• Support global strategy through development of market intelligence, competitive intelligence and product launches• Support Global Marketing Director and GMO team on product portfolio strategy• Support GMIA with market feedback and competitive trends• Identify and evaluate new market segments and customer needs• Analyze and report on market potential in relevant markets• Identify competitive threats and develop contingencies• Support new product launches in local markets (forecasting, positioning, tactics, product training, marketing materials and event/conference activities)• Support best practices throughout the organization• Conduct product training of country-level sales- and marketing associates• Prepare and support required internal approvals using established corporate change processes (e.g. CPLR, C/WR)• Self-manage all other indispensable workMarketing Campaigns and product positioning • Develop marketing briefs to aid the marketing agency in development of messaging for new product launches• Along with marketing agency develop global product positioning and USPs for new product launches• Along with marketing agency develop marketing materials and web-content for new product launches• Provide local marketing teams with global campaign materials and supportOther duties as needed or required

ESSENTIAL FUNCTIONS OF THE ROLEAbility to travel up to 30% of the time.

QUALIFICATIONS

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Academic Qualifications• Bachelor’s in Business, marketing, healthcare, or a technical discipline required• MBA or equivalent degree highly preferredExperience• 7-10 years of overall business experience, 3-5 years of experience in marketing, preferably in medical device or healthcare industry• Project management experience is requiredSpecialized Skills/Other• Strong relationship management and communications skills required• Project management experience required• Healthcare and/or medical device experience required• Product launch experience required • Robust analytical ability and understanding of forecasting process required• Strong understanding of healthcare/medical devices environment required• Solid understanding of healthcare reimbursement policies and potential impact on company strategy• Team leadership experience preferred• Experience developing and executing marketing plans/campaigns preferredCandidate must be local to IL.

MARKETING MANAGER (CONSUMER MEDICAL PRODUCTS) - MIDWEST

Client’s product is uniquely designed to support people with an ostomy or bladder management needs. It is strategically important to both the Ostomy and Continence Care business strategies as a means to interact closely with consumers with the intent to drive satisfaction with company. The Marketing Manager will be responsible for developing the overall marketing strategy, as well as designing, developing and executing brand guidelines, positioning, messaging and supporting tools for product coordinators, field sales. This position will also manage strategy and content for this product’s website and all other consumer-directed marketing. This position will need to closely collaborate with product line marketing managers and product-specific managers.

RESPONSIBILITIES Marketing Strategy FormulationDevelop short, medium and long-term marketing strategy in alignment with overall strategy Translate marketing strategy into well-thought out annual marketing plans. Understand market, customer and competitive trends and factor into marketing strategyDevelop, Execute, and Monitor for Consistency of the Brand Guidelines and Positioning (in alignment with overall Strategy)Continue to review/enhance existing brand guidelines. Liaise with Corporate Communications and Global Marketing to ensure alignment to corporate and global guidelines. Liaise with Business Unit marketing to ensure alignment with Business Unit strategy and positioning. Ensure all marketing collateral and communication vehicles adhere to the brand guidelines and positioning. In collaboration with product-specific Managers and Business Unit sales and marketing management, develop process for ongoing monitoring of messaging consistency and correct usage of marketing collateral

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Healthcare Facility Setting: Design, Develop, and Implement Marketing Strategy, Messaging and Associated Tools for Coordinators, Field Sales, and Health System KAMs across Ostomy and Continence CareDevelop an annual marketing plan for this audience. Co-travel and attend key customer events to stay current on customer needs. Develop briefs for each marketing piece and effectively communicate scope and approach to agency. Project manage agency to ensure timely delivery of high-quality deliverablesCoordinate with Business Unit marketing to gather feedback from all relevant stakeholders on marketing promotion and/or new service enhancements required Manage pink sheet process with support from marketing coordinator. Lead the development and execution of the product’s portion (within Business Unit section) of sales meetings, including conducting training as needed. Lead the development and execution of conference booth strategy for product section, in coordination with Business Unit MarketingCommunity Setting: Design, Develop, and Implement Marketing Strategy, Messaging and Associated Communication Vehicles Targeted Directly at Ostomy and Continence Care ConsumersDevelop an annual marketing plan for this audience. Regularly listen in on consumer calls, attend consumer association and/or support group events, and company-sponsored patient panels to stay current on customer needs. Develop briefs for each marketing piece and effectively communicate scope and approach to agency. Project-manage agency to ensure timely delivery of high-quality deliverables. Coordinate with Business Unit marketing to gather feedback from all relevant stakeholders on marketing promotion and/or new service enhancements required. Manage materials approval process with support from marketing coordinator. Lead the development and execution of product portion of consumer events in coordination with Business Unit Marketing. Act as website manager, ensuring content is current, consistent and relevant to our customersCoordinate and Collaborate with internal stakeholders to ensure full alignmentCoordinate/collaborate with U.S. Ostomy and Continence Care Marketing teams to ensure services’ messaging is in alignment with overall business strategy, and that product element of the overall business unit portfolio strategy is well understood by Field Sales. Solicit Business Unit sales and marketing management input on what specific marketing programs and tools are required to best support the BU Sales and Marketing Plan. Ensure tight alignment during Annual Operating Plan (AOP) and Mid-Year Review (MYR) planning. Participate in Business Unit marketing team meetings as needed. Coordinate/collaborate with Ostomy and Continence Care managers to ensure that what is marketed can be executed. Solicit their input on what marketing programs and tools are required by various internal stakeholders. Provide input to them regarding new service enhancements that may be required. Liaise with Compliance on development of all written messaging, tools, etc. Keep Business Unit Ostomy/Continence Care Leadership and Global Marketing up-to-date on strategies and tactics

MiscellaneousManage operating expense budget, including presenting at annual budget meetings. Keep up-to-date on Global Marketing best practices and marketing plan templates. Attend internal Marketing training programs. Participate in monthly product leadership team meetings and provide input on Development Succession Review (DSR), team-building and resolution of product organization-wide issues and/or opportunities. All other projects as assigned

QUALIFICATIONS Academic/Credentials/Certifications· BS/BA degree· MBA preferredLength of experience

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· 8-12 years of marketing or marketing communications experience (ideally in consumer industry)· At least 3 years of experience in a consumer-based, regulated industry

Specialized skills/technical knowledge· Experience in developing innovative strategies and driving the execution of the strategies· Demonstrated quantitative analysis skills.· Strong verbal and written communication skills· Strong cross-functional relationship management skills· Proven track record of delivering results; self-starter· Strong business acumen/thinking sills· Sr. Management presentation/interaction skills· Basic computer knowledge (e.g., Microsoft office)· Experience with CRM systems and/or SF.com· Experience with website management (optional)· Marketing Communications/Advertising Agency experience (optional)

INDIANA

Automation Process Engineering Lead – Indiana JOB DESCRIPTIONUsing a disciplined process management approach—this position will team with La Porte’s manufacturing operations in developing and implementing sustainable and standardized post-cast finishing processes such as CNC processes, cutting, sandblasting, plus rework operations that will lead to high product yield. Driving standardized post-cast processes and process management using the scientific method and six sigma tools.• Ensuring development and implementation of new materials and finishing techniques rooted in six sigma methodology.• Leading a team of technicians in the development of robotic (Motoman/Fanuc) and CNC programs throughout the facility, inclusive of fixture design for; shell build, shell removal, blasting media, digital radiography, welding, and casting units.• Creating and maintaining a project list for each project including project cost, required machine time for development and personnel involvement.• Validation of programming / automation changes to downstream key output variables via communication with other technical teams and the six sigma methodology.• Creation and maintenance of a system for revision change control on all automated programs.• Development of an off-line programming tool, including educating a team of technicians on its use.• Coordinating and planning projects and resources with new vendors and customers.• Writing capital requests, managing costs and controlling budgets for specific post-cast projects and objectives.• Creation of a system capable of tracking consumable products and anticipated cycle time by operation/part number. REQUIREMENTS· Bachelor's Degree [Engineering Preferred]· 5+ to 7 years of experience

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· Must have experience with Motoman, robotics, CNC equipment and experience in the casting and automotive industry.· Must have supervisory experience.· Familiar with six sigma methodology· Process management in manufacturing operations· Full RelocationOccasional travel

LOUISIANA

Mechanical Engineer - Oil & Gas/Refinery or Chemical Industry & Reliability Experience) Southern LouisianaPosition is on-site and full time:- Client is offering relocation assistance.- MUST EITHER be a U.S. Citizen or Green Card Holder.- No Third-party recruiters, please. Provide mechanical engineering support for the chemical Plant. Lead plant’s mechanical reliability to achieve increase reliability.

MAJOR RESPONSIBILITIES:Provide mechanical engineering support for most reliable operation and lowest life cycle cost for rotating and fixed equipment in world class solids manufacturing and handling facility.

Support Reliability Centered Manufacturing to improve occupancy and to reduce costs to best in class.KEY SKILL’s (Must have):Safety 1st mindset.· 5 to 15 years of experience in plant engineering dealing with rotatory/ fixed equipment· Proven ability to work with operations, safety, and other functional teams

Demonstrated successes related to mechanical equipment such as cost improvements projects, improvements in MTBF and elimination of chronic problems through root cause analysis. Candidate MUST be self-motivated, highly skilled, team player with exceptional cost focus. Individual should be results oriented with continuous improvement mindset.Must have excellent cost focus and desire for continuous improvement. Must be capable of drawing others to action; able to influence others to targeted outcomes.BASIC QUALIFICATIONS (Must have):

2 plus years of related experience in a Chemical, Petrochemical or petroleum production or refining facility (desired)Candidate should excel technically and be familiar with all aspects of rotating and reciprocating equipment and vessel and piping systems common in Chemical plants. Familiar with all ASME, API standards and reliability best practices. Minimum Required: BSME

ADDITIONAL QUALIFICATIONS (Preferred):Solids handling

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Maximo report generationMaximo report generationProject management - $1MM+ projects5s and/or Lean manufacturing training

MINNEAPOLIS

APPLICATIONS SOFTWARE ENGINEER - MNGenerous base salary

Manages software development engineers responsible for design, development and verification of software sub-systems and components for server- and PC-based medical software and tools. Seeking mobile applications including SaaS/cloud-based technologies experience, and ideally seeking strong embedded/firmware knowledge.)

NOTE: PLEASE REQUEST JOB DESCRIPTION

DIRECTOR SOFTWARE ENGINEERING - MN Generous base plus 40% bonus potential 

We are conducting a search for a Director of Software Engineering to staff and lead a team of 30 engineers designing, developing, documentation  and verification  of components and sub-systems for PC and server platform-based medical software. This team will also develop the software tools to meet product specific requirements. (Embedded/firmware required. Also seeking mobile applications including SaaS/cloud-based technologies experience)

PLEASE REQUEST JOB DESCRIPTION

NEW JERSEY/NEW YORK

DIRECTOR, INTERNATIONAL REGULATORY AFFAIRS / QUALITY (MEDICAL DEVICES) - NJ (Experience with Japan Regulatory Environment) – ON HOLD

The Director of International Regulatory Affairs has the overall responsibility to develop, facilitate and execute comprehensive Japan regulatory strategies to accelerate and ensure successful product registrations for both new product launches and change management to commercialized product registrations. While the scope of responsibility is primarily Japan, the position will provide leadership in other areas of International Regulatory Affairs as requested.The Director of International Regulatory Affairs reports directly to the Staff Vice President Regulatory Affairs and will work closely with the Division and International Business Center (IBC) project teams in the development and execution of regulatory submissions.Must be able to interpret and effectively deal with complex regulatory issues across business units in support of both division and corporate goals. Must possess excellent communication (both written and verbal), influential and negotiating skills, allowing the effective communication of complex regulatory information to a wide variety of audiences and leveraging for the best outcome. Must be a collaborative facilitator and leader, building

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consensus while championing global regulatory initiatives. Using knowledge of Japan and other international regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner. Analyze current processes, develop regulatory metrics and scorecards and institute data-based process improvements for Japan which will facilitate the product registration process and align with corporate and business unit goals. Develop and foster professional working relationships with Japan regulators (MHLW/PMDA and with industry associations (i.e., AdvaMed). Provide technical leadership and vision through the interpretation of new and emerging Japan regulatory trends pertinent to the business unit needs and implement strategies and projects to optimize regulatory performance in light of these trends. Essential Job Functions:Work with Divisions and outside partner organizations to provide quality and regulatory direction in accordance with procedures. In collaboration with Divisions, develop strategies for field actions and holds in Japan Oversight for complaint reduction programs to assure Divisional and outside organization’s goals are on target.Basic Qualifications:The incumbent will have:• Evidence as a regulatory and quality leader with a minimum of 8 years of experience in a regulated health industry, with a strong concentration in medical devices.• Minimum of 2 years of experience in senior regulatory affairs management/quality assurance responsible for international registration of medical devices preferably Japan.• Significant experience interfacing with international regulatory authorities including Japan with a proven track record of numerous successfully completed medical device product approvals.• Capability of assuming the leadership for management and ownership of Japan product registrations.• Excellent written and verbal communication along with strategizing and influential strengths. Must be able to manage by influence as the position has no direct reports but relies heavily on other units and divisions within the organization to achieve goals.Ability to manage differences in international business cultures and standards along with language translations to obtain successful and timely product registrations.

Additional Desirable Qualifications Skills and Knowledge:Experience as a senior manager of within a large matrix-managed organization would be beneficial. Fluency in Japanese would be a benefit. Education and/or Experience:A bachelor’s degree in biological, health sciences or physical sciences. An advanced degree is preferred. Physical Demands:Able to travel internationallyWork hours to meet the needs of the international businessWork Environment: Office

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Training Requirements:Regulatory and Clinical proceduresJapan Medical Device Regulatory requirements

SOUTH CAROLINA

SENIOR PROCESS ENGINEER (PRODUCT TECHNOLOGY) SCSalary Range is $80-100K depending upon experience plus 10 % bonus eligibility target

Works independently or in conjunction with other engineers, plant managers, production superintendents, and/or production, and maintenance personnel both in-house and at customer level in analyzing and developing solutions to processes for in the direct support extrusion, printing, and converting processes. This includes design and development of new processes, product modifications including product line extensions, raw material replacements, and supports stage gate projects across business units.Responsibilities:· Working independently or with others to develop improved methods for delivering finished product to our customers.· Works with the Business Unit Leaders to define product modifications in order to meet specific market needs relative to the extension of an existing product line.· Serves as the primary Supply Chain representative for stage gate projects across all businesses.· Leads identification and qualification of alternate resins and raw materials both for cost savings, obsolescence, and business continuity purposes.· Interacts with customers, T&I, Business Unit Leaders, and other Process Engineering functions, to identify new or improved products or methods for delivering value-added products to customers.· Identifies opportunities to remove costs from current and new operations.· Stay abreast of new equipment / process developments in the Plastics Extrusion field· Communicate regularly to share combined knowledge with process engineers in other locations· Serves as independent expert to troubleshoot manufacturing problems and identify solutions with data based decision making as needed.· Identify and implement new/improved methods of manufacturing to improve profitability· Consistently demonstrates ability to solve complex problems and consistently moves multiple projects to timely & successful conclusions. Takes a leadership role in cross functional teams. Is given the most complex EH&S compliance problems to correct.· Applies advanced technical knowledge and or new technology to the manufacturing process to increase customer satisfaction and safety by:o (1) better products through transitions, development, and trade secrets,

o (2) less variation,

o (3) greater efficiency through improvement of reliability, rates yields and quality,

o (4) less complexity through long term solutions to eliminate day to day troubleshooting,

o (5) improved equipment , and

o (6) better process with shorter setup and cycle time.

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· Bachelor of Science in Chemical, Electrical, or Mechanical Engineering Required.· Requires experience with varied manufacturing processes such as extrusion, printing, laminating and converting.· Requires knowledge of statistical techniques and tools, their use and interpretation· Requires ability to manage a project and process involving multiple manufacturing areas, plants, and s various portions of the business.· Three plus years of experience· performance work environment - Demonstrated flexibility within a matrix managed organization.· Excellent written and verbal communication skills along with professional presentation and negotiation skills.· Has demonstrated ability to work independently and focus on critical project parameters that determine success of failure. PPE· Minimum three years prior experience in a Process Engineering or Development engineer type position.· Experience in new product and/or process development.· Knowledgeable of statistics preferredSPC· Designed experiments, Lean Six Sigma, or equivalent experience preferred· Self-starter capable of working independently with minimal supervision.· Works around rotating equipment, hot polymers, and high noise environments.· Required to wear safety shoes as well as standard.· Exposed to various chemicals throughout the site.· Comply with all established facility safety rules and policies. · Attend and participate in monthly safety meetings. · Report unsafe conditions or injuries immediately.

TENNESSEESR. INDUSTRIAL ENGINEERThis position will work with management to improve methods and workplace layouts resulting in increased productivity and facility throughput using proven industrial engineering techniques. This position would also be responsible for testing, analysis, work measurement, presentations, change management, project management, product evaluation, and cost justifications. This position will also include but not be limited to the introduction of new handling equipment, processes, and information systems intended to improve the total productivity and throughput of the facility while maintaining a safe environment for our employees.

DUTIES AND RESPONSIBILITES:• Performs process analysis to determine productivity barriers recommend and assist implementing solutions for removing the barriers • Performs method analysis to determine the best method to perform the best practices considering safety, ergonomic, and fatigue factors • Documents elemental breakdown of all job tasks for use in standard operating procedures and training• Performs work measurement to determine the time required to perform the accept methods

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• Calculates standards, gain acceptance of standards, implement standards, and work with management to obtain the standards• Oversees all local aspects of a labor management system• Assist with budgeting as necessary• Works with various company and outside partners to ensure company’s quality standards are met

KNOWLEDGE SKILL AND ABILITIES: Individual must have a thorough knowledge of work measurement disciplines. These may

include time study, methods time measurement, universal standard data, master standard data, etc.

This individual should have knowledge of distribution processes and be a good fit for working in an environment where a systematic, data-oriented approach to managing people at work is used and relies on positive reinforcement as the major way to maximize performance.

This individual will have a good understanding of warehouse management inventory systems Strong computer skills Excellent verbal and written communication skills Strong analytical skills

Candidate must have Experience with time studies Experience with labor management systems Ability to travel 50% of the time

WORK EXPERIENCE AND/OR EDUCATION: Bachelor’s degree in Industrial Engineering or related field required.

At least 4 years of warehouse experience required. An equivalent combination of education and experience may be substituted

WORKING CONDITIONS:This individual must be able to conduct extended studies and research in a high-speed, non-air-conditioned distribution center environment with exposure to dust and noise.

*Position will require some travel.

Compensation will consist of a competitive salary based on your experience, with bonus potential.

TEXAS

PROJECT ENGINEER: Plastics/Polymers/Thermoplastics- TXResponsibilities:· Provide technical leadership to support the needs of plant projects and make sound technical decisions· Collaborate with staff to facilitate ongoing capital projects within the Plant· Review drawings and specifications to determine requirements of plant projects· Organize, prepare and maintain project information and documentation· Track project costs

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· Interact with production personnel to define and solve manufacturing/design issues and implement cost reduction ideas· Coordinate project needs with maintenance and contractors· Act as a liaison between Engineering and other manufacturing operations for related issues, problems or improvements· Prepare technical data such as test procedures and reports· Update process and instrumentation diagrams· Estimate, prioritize, and write appropriation requests.· Participate in engineering and general design review meetings as required· Design and implement projects that are engineered for safety, operability, and reliability.· Seek out new opportunities to improve the HS/E and cost performance of the plant· Skills, Qualifications, Experience, Special Physical Requirements: Requirements· Bachelor of Science in Chemical Engineering or similar discipline required· A minimum of three years of related experience and/or training required· Experience in Project Management· Able to read, analyze, and interpret the most complex documents· Able to use computer assisted drafting (CAD) equipment and software· Able to comprehend and apply principles of calculus, modern algebra, and statistical theory· General PC skills, familiarity and proficiency in MS Project and other MS Office applications.· Excellent communication skills· Person must be comfortable working with vendors, crafts, engineers, manufacturing employees and other maintenance· Must have the facilitation skills to lead groups in the various problem solving techniques· Experience in multi-tasking, prioritizing complex issues and managing multiple projects

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SUPERINTENDENT OF MINING, TXREQUIREMENTS:•Bachelor of Science Degree in Engineering preferred (preferably Mining or Civil) or equivalent experience required•5+ years of plant management experience at a mining operation•Working knowledge and understanding of MSHA regulations and possess a strong personal commitment to safety•Self-starter with excellent verbal, written and interpersonal communication skills; capable of developing and maintaining good relationships with company and regulatory agency personnel•Strong leadership skills; possess the ability to lead, manage and motivate; have a proven track record for creating employee ownership of safety, production and quality•Excellent time management skills; ability to prioritize and manage multiple tasks; strong planning skills•Proficient in Microsoft Word, Excel, PowerPoint, and Outlook preferred•Process oriented and can facilitate the use of systems Benefits:· Competitive salary· Bonus· Relocation· Medical· Prescription Drug

.

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SOUTHWESTERN US OR UTAH

SENIOR ENGINEER – TYPE 1 (MEDICAL DEVICES)

This is a high-level research and development engineering position.

Requires a high-energy individual with excellent teamwork, partnering and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development / quality / manufacturing experience in new product and process development. Responsible for both the technical aspects of product design and development as well as the translation of marketing requirements into product specifications.

Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

Essential Job Functions:Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.Maintains a professional working relationship with internal & external customer and support staff.Participates and leads cross-functional teams.Provides technical support on components, material methods, systems and equipment.Develops physical and functional test requirements to assure specifications and regulations are met. Writes and approves protocols, reports and data.Manages testing outlined in protocols and test methods.Manages/develops validation studies on equipment & processes.Conduct complaints investigations.Understands and follows company procedures and regulatory requirements.Participates in and provides input to training on department & division procedures, and policiesManages project planning, budgeting, scheduling and tracking.Plans and coordinates engineering test builds.Analyzes problems in design, process and test development. Recommend/implement solutions.Prepares and presents oral and written project updates and technical discussions.Develops and implements procedures/policy.

Basic Qualifications:1. Experience as the lead R&D engineer on a medical device product development program2. Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for (), and specification development3. Design capability with small plastic and metal parts4. Demonstrated proficiency with Geometric Dimensioning and (GD & T)5. Working knowledge of various materials typically used in medical devices6. Significant experience in product verification and validation testing, medical device new product development and rapid prototyping.

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7. Experience in product verification via test equipment development and equipment validation (IQ//) within an FDA regulated or other regulated industry (i.e. bio-tech/, aerospace, etc.).8. Clinical trial and/or animal trial experience9. Proficient in technical writing of protocols and reports. 10. capability in writing clear and detailed testing and product assembly procedures. 11. Impeccable documentation skills and adherence to design control procedures and12. Demonstrated experience in application of lean manufacturing principles.13. Comfortable in a dynamic working environment 14. Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Design of Experiments) Additional Desirable Qualifications Skills and Knowledge:A Bachelor's degree in Mechanical Engineering is preferred.Requires a high-energy individual with excellent teamwork, partnering and negotiation skills.Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must.

Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

Education and/or Experience:Bachelors degree in engineering and a minimum of five (5) years experience within the medical device industry, or a Master’s degree and a minimum of four (4) years of engineering experience within the medical device or equivalent industry.

Physical Demands:While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

SENIOR ENGINEER – TYPE 2 (MEDICAL DEVICES)

This is a high-level research and development engineering position. High level and hands-on engineering position that leverages medical device development / quality / manufacturing experience in new product and process development. Responsible for both the technical aspects of product design and development as well as the translation of marketing requirements into product specifications.

Essential Job Functions:Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.

Maintains a professional working relationship with internal & external customer and support staff.

Participates and leads cross-functional teams.

Provides technical support on components, material methods, systems and equipment.

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Develops physical and functional test requirements to assure specifications and regulations are met. Writes and approves protocols, reports and data.Manages testing outlined in protocols and test methods.Manages/develops validation studies on equipment & processes.Conduct complaints investigations.Understands and follows company procedures and regulatory requirements.Participates in and provides input to training on department & division procedures, and policiesManages project planning, budgeting, scheduling and tracking.Plans and coordinates engineering test builds.Analyzes problems in design, process and test development. Recommend/implement solutions.Prepares and presents oral and written project updates and technical discussions.Develops and implements procedures/policy.Basic Qualifications:1.Experience as the lead R&D engineer on a medical device product development program2.Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for (), and specification development3.Design capability with small plastic and metal parts4.Demonstrated proficiency with Geometric Dimensioning and (GD & T)5.Working knowledge of various materials typically used in medical devices6.Significant experience in product verification and validation testing, medical device new product development and rapid prototyping.7.Experience in product verification via test equipment development and equipment validation (IQ//) within an FDA regulated or other regulated industry (i.e. bio-tech/, aerospace, etc.).8.Clinical trial and/or animal trial experience9.Proficient in technical writing of protocols and reports. 10. capability in writing clear and detailed testing and product assembly procedures. 11.Impeccable documentation skills and adherence to design control procedures and12.Demonstrated experience in application of lean manufacturing principles.13.Comfortable in a dynamic working environment 14.Demonstrated ability in using statistical experimental design and analysis techniques (i.e. Design of Experiments) Additional Desirable Qualifications Skills and Knowledge:A Bachelor's degree in Mechanical Engineering is preferred.Requires a high-energy individual with excellent teamwork, partnering and negotiation skills.Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must.Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

Education and/or Experience:Bachelors degree in science or engineering and a minimum of six (6) years experience within the medical device industry, or a Master’s degree and a minimum of five (5) years of engineering experience within the medical device or equivalent industry.

Physical Demands:While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.

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REGULATORY AFFAIRS COMPLIANCE MANAGER -(MEDICAL DEVICES)

This position implements FDA compliance, MDD compliance, and policy and process compliance. This position may also act as a liaison to Corporate Law Department, providing requested information.

Essential Job Functions:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.1. Responsible for implementing and maintenance of regulatory policy and procedure in compliance with relevant laws and regulations. 2. Responsible for FDA Device Listings, Establishment Registrations, Annual Reports, and compliance to and maintenance of state licensing. 3. Responsible for regulatory management of new FDA requirements (e.g., UDI) as they become known. 4. Responsible for supporting FDA audits of the company's facility. 5. Responsible for MDD compliance, preparation and maintenance of EU Design Dossiers and Technical Files. 6. Responsible for Notified Body Technical File Audits, and supporting other Notified Body Audits. 7. Domestic and International travel as required.

Basic Qualifications:This position requires a Bachelors Degree in Life or Engineering Science, eight (8) years regulatory affairs experience or equivalency, or 6 years with post-graduate degree. Extensive knowledge of U.S. FDA regulations, policy and procedure. Extensive knowledge and experience with the MDD and CE marking, including surveillance and technical file audits. Knowledge of product registration requirements in Australia and Canada. Demonstrated communication and human relation skills. The incumbent also must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

Additional Desirable Qualifications Skills and Knowledge:1. Understanding of US, CE and international medical device regulations. 2. High scientific, analytical evaluation skills. 3. Good written and oral communication skills. 4. Ability to manage direct reports and diverse projects.

Physical Demands:This position is in an office environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. Bending, stooping and reaching are also frequently required.

GROUP DIRECTOR, REGULATORY AFFAIRS/QUALITY AFFAIRS (MEDICAL DEVICES)

General Position Summary: This position is responsible for ensuring regulatory and quality compliance with Federal, State and local regulations pertaining to GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory agencies through effective management of the company’s Product Quality.

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Core Responsibilities: Perform duties of Management Representative:• Act as liaison with 3rd party inspectors (e.g. FDA, Notified Body, customers)• Review and analyze Quality System data and report to Executive Management on the state of the Quality System• Ensure Quality System compliance to relevant regulations and standards• Provide regulatory support for Product Development • Participate in regulatory planning from the beginning of a project• Participate in design reviews to ensure compliance with design control requirements• Provide internal validation services• Evaluate design changes for updates to regulatory submissions

Supervise Regulatory Affairs:• Regulatory submissions• Maintenance of licenses, registrations, etc.• Post-market surveillance activities• Corrections, removals, and recalls per regulatory requirements• Medical Device Reporting, Incident Reporting, etc. per regulatory requirements. Participate in product acquisition activities:• Review acquisition to ensure applicable quality and regulatory records are obtained• Transfer regulatory registrations, etc. • Participate in acquisition project to evaluate any design changes or changes in market location that could lead to regulatory submission changes. Manage Quality Organization:• Work with Quality Manager, Quality Technicians, Quality Engineers and Document Control Specialist to perform their duties in support of company objectives• Provide clear objectives and goals to the Quality group• Measure progress toward goals

Supervisory Responsibilities: This position supervises the company’s Quality and Regulatory Managers and their direct reports.

Miscellaneous• Complete required training in a timely manner• Assist other Quality Managers with their duties as needed

Education and/or Experience:• Requires a Bachelor or Master’s degree, or ten years related experience and/or training; or equivalent combination of education and experience relevant technical training.• Requires at least 10 years operating experience in Quality and Regulatory function in a related industry

Other Qualifications:• Able to master new concepts, applications and stay up to date on industry standards• Able to work effectively managing teams or independently to meet business needs• Able to succeed in highly regulated compliance oriented environment while still providing service excellence• Possess knowledge and understanding of current Quality techniques and industry standards and their impact on internal procedures, quality, and safety and efficacy of products.• Thorough knowledge of ISO 13485, ISO 9001, IEC 60601, Medical Device Directive, and Canadian Medical Devices Regulations

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• Must have excellent verbal and written communication skills, including being able to communicate effectively with all levels of staff, executive management and customers, via in person, phone or email• Proficient with Microsoft office programs (Word, Excel, PPT, Project etc.)• Excellent time management and prioritization skills in order to complete responsibilities on time and within budget• Prior supervisory experience• Able to succeed in highly regulated compliance oriented environment while still providing service excellence• Provide a positive, professional, empathetic and customer-focused demeanor• Ability to apply advanced mathematical concepts and reasoning skills to support Quality and Regulatory analysis and decisions

Preferred Qualifications:• Certified Quality Manager• Certified Lead Auditor Regulatory Affairs Certification (RAC) – United States • Regulatory Affairs Certification (RAC) – Europe

INTEGRATION PROJECT MANAGER (M&A: Medical Devices) This position is responsible for the planning, managing and reporting activities for business development integration and product development projects. This position has the primary responsibility to deliver safe, compliant business outcomes on time. This responsibility includes: evaluation of potential acquisition targets, management and review of due diligence activities, development and management of acquisition integration plans, and overall responsibility for the logistics associated with the onload of acquired assets. This position has primary cross-functional responsibility for directing the integration of acquired businesses or technologies. This position may also direct non-integration product development project plans, cost improvement projects, manufacturing location transfers, etc. To ensure the success of their project, they must ensure the success of each individual or function (QA, RA, CA, Marketing, Ops and R&D) within the team they manage.

MINIMUM QUALIFICATIONSThis position requires a Bachelors Degree in a technical field plus ten years experience or equivalency in the medical device or closely related industry. Five years experience in project management and four years in a direct supervisory/management role is preferred. PMP certification is also preferred. Good working knowledge of design controls, development, manufacturing, finance, administration and some knowledge of clinical requirements for medical devices required. Demonstrated positive communication and human relation skills are also necessary requirements for the position The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities. ESSENTIAL DUTIESThe following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position. 1. Organizes and coordinates all activity related to their project.

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2. Performs managerial responsibilities for direct reports, which may include performance reviews, selection, promotion and disciplinary recommendations.3. Performs managerial responsibilities for the project, which includes development of project plans and schedules, identification of required human resources, budget requirements and prioritization.4. Works with cross-functional team members in support of division goals ensuring the project plan includes all functional activities from initiation through project completion. 5. Creates tracks and meets project schedules and budgets.6. Assesses priorities and makes assignments to assure project and company priorities are met.7. Develops, with divisional managers, a strategic direction for each project and communicates vision to the cross-functional teams.8. Assures compliance with corporate and divisional procedures, policies and government regulations.9. Identifies development needs and potential for team members and provides/recommends project assignments and training to increase expertise to meet current or future division needs.10. Develops the performance standards and the norms of the project team and assures team communication with division management.11. Provides timely information to divisional management on issues which will affect the division’s performance. KNOWLEDGE SKILLS AND EXPERIENCE 1. Ability to concurrently handle a variety of projects while coordinating and supporting the efforts of cross-functional team members.2. Ability to independently work with in-house and outside suppliers, contractors and consultants.3. Ability to independently work with outside medical and technical professionals.4. Skills in communicating with all levels of technical and operating management (both written and oral presentation skills).5. Highly developed skills in project management, including the use of Microsoft Project or other common project management software.6. Ability to analyze and use technical data and resources.7. Knowledge of the clinical environment of the division products.8. Leadership and decision making skills.9. Ability to understand all dimensions of customer requirements.10. Knowledge of Business Management skills in the areas of finance, capitalization, business planning, regulatory and product development.

PHYSICAL REQUIREMENTSThis position is in an office environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. Bending, stooping and reaching are also frequently required.

This position reports to the Director / V.P. PRINCIPAL CHALLENGES- PROBLEM SOLVING 1. Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.2. Written Comprehension - The ability to read and understand information and ideas presented in writing.

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3. Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.4. Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).

Director, Product Development (Medical Devices)

Overview:This position is responsible for the management of division activities related to multiple product development groups, including product development, cost improvement, manufacturing support, and compliance to divisional FDA requirements.Summary of Position with General Responsibilities:..Essential Job Functions:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position. Organizes and coordinates all activity related to multiple product development groups and associated technology teams. Performs managerial responsibilities for assigned team members, which may include performance reviews, selection, promotion and disciplinary recommendations. Works with Sales and Marketing to create product development strategies.  Monitors sales forecasts, sales actuals and customer feedback. Creates tracks and meets project schedules and budgets. Implements department and division procedures and policies relating to all aspects of the product development groups and technology teams. Assesses priorities and makes assignments to team members to assure project and company priorities are met. Develops, with divisional managers, a strategic direction for product development groups and communicates vision to technology teams. Assures compliance with corporate and divisional procedures, policies and government regulations. Coordinates with team members and outside professionals to assure product designs and processes meet users’ needs, as well as all applicable FDA requirements.  Coordinates resource allocation and balancing for technology teams. Identifies development needs and potential for team members and provides/recommends project assignments and training to increase expertise to meet current or future division needs. Develops the performance standards and the norms of the product development teams and assures team communication with division management. Provides timely information to divisional management on issues which will affect the division’s performance. Manages and maximizes the intellectual property and new product/process opportunities of the assigned product

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line(s).Assures that the growth of the assigned product line(s) is maximized within the constraints of the market environment.Basic Qualifications:This position requires a Bachelors Degree in a technical field plus ten years of experience or equivalency in the medical device or closely related industry. MBA is preferred.Five years of experience in project management.Four years in a direct supervisory/management role is preferred.Good working knowledge of development, manufacturing, finance, administration and some knowledge of clinical requirements for medical devices required. Demonstrated positive communication and human relation skills are also necessary requirements for the position.

Additional Desirable Qualifications Skills and Knowledge:Ability to concurrently handle a variety of projects and coordinate the efforts of cross-functional team members. Ability to independently work with in-house and outside suppliers, contractors and consultants. Ability to independently work with outside medical and technical professionals. Skills in communicating with all levels of technical and operating management (both written and oral presentation skills).Skills in project management. Ability to analyze and use technical data and resources. Knowledge of the clinical environment of the products assigned to the team. Leadership and decision making skills. Ability to understand all dimensions of customer requirements. Knowledge of Business Management skills in the areas of finance, capitalization, business planning, regulatory and product development.

PROGRAM MANAGER (MEDICAL DEVICES)This position is responsible for the management of new product development activities within a business franchise. They have primary responsibility to deliver safe, compliant business outcomes on time. This responsibility includes: product development, cost improvement, manufacturing support, sustaining engineering, shared service groups and compliance to divisional FDA requirements. To ensure the success of their franchise, they must ensure the success of each individual or function (QA, RA, CA, Marketing, Ops and R&D) within the team they manage.

Essential Job Functions:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

Organizes and coordinates all activity related to their product franchise or product development group. Performs managerial responsibilities for assigned team members, which may include performance reviews, selection, promotion and disciplinary recommendations.Works with cross-functional team members in support of division goals. Establishing a product development plan that includes all functional activities from concept through product discontinuation. Creates tracks and meets project schedules and budgets.Implements department and division procedures and policies relating to all aspects of the product development groups and technology teams. Assesses priorities and makes assignments to assure project

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and company priorities are met. Develops, with divisional managers, a strategic direction for product development groups and communicates vision to technology teams.Assures compliance with corporate and divisional procedures, policies and government regulations.Coordinates with team members and outside professionals to assure product designs and processes meet user’s needs, as well as all applicable FDA requirements. Coordinates resource allocation and balancing for technology teams. Hires and develops staff in technical roles.Identifies development needs and potential for team members and provides/recommends project assignments and training to increase expertise to meet current or future division needs.Develops the performance standards and the norms of the product development teams and assures team communication with division management.Provides timely information to divisional management on issues which will affect the division’s performance.

Basic Qualifications/REQUIREMENTS:· Bachelors Degree in a technical field plus ten years of experience or equivalency in the medical device or closely related industry.· Five years of experience in project management and four years in a direct supervisory/management role is preferred.· Good working knowledge of design controls, development, manufacturing, finance, administration and some knowledge of clinical requirements for medical devices required. Demonstrated positive communication and human relation skills are also required

The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

Additional Desirable Qualifications Skills and Knowledge:Ability to concurrently handle a variety of projects while coordinating and supporting the efforts of cross-functional team members.Ability to independently work with in-house and outside suppliers, contractors and consultants.Ability to independently work with outside medical and technical professionals.Skills in communicating with all levels of technical and operating management (both written and oral presentation skills).Skills in project management.Ability to analyze and use technical data and resources.Knowledge of the clinical environment of the products assigned to the team.Leadership and decision making skills.Ability to understand all dimensions of customer requirements.Knowledge of Business Management skills in the areas of finance, capitalization, business planning, regulatory and product development.

Physical Demands:This position is in an office environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. Bending, stooping and reaching are also frequently required.

REGULATORY AFFAIRS SPECIALIST II, UT

This position implements domestic and international regulatory affairs (RA) procedures. This 

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position may also act as a liaison to Corporate Law Department, providing requested information. The ideal candidate must be able to work in a team oriented, fast paced environment. Client is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Summary of Position with General Responsibilities:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position. 1. Serves as RA representative on project teams. 2. Coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new products. 3. Performs RA reviews for labeling change requests. 4. Coordinate the preparation of International Dossiers with the Product Teams and disseminate the dossiers to the appropriate parties. 5. Travel as required (approximately 5%) 1. Understanding of US, CE, and international medical device regulations. 2. High scientific, analytical evaluation skills. 3. Good written and oral communication skills. 4. Ability to work well within cross-functional teams. 

KNOWLEDGE AND SKILLS:

Essential Job Functions: Basic Qualifications:Bachelor’s Degree in Life or Engineering Science, Business, or equivalency. Four years regulatory affairs experience or equivalency, or three years with post-graduate degree. Regulatory experience with premarket notification submissions to FDA and 510(k) compliance. Demonstrated communication and human relation skills.

Senior Engineer (Medical Device/Life Science) - Western  Rocky Mountain Region of US (Up to $100K plus 10% Bonus potential)

Overview:This position is responsible for system development and improvement along with managing projects with divisional impact.

Summary of Position with General Responsibilities:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

Scope• Consultant/Division expert• Develops Innovative ideas for the organization• Division technical expert• Broad business and technical understanding• Coach/Mentor• Influences and directs others across organization• Results Oriented• Critical Decision Maker in areas of engineering and business needs• Project Leader• Networking savvy• Representative of BAS 

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Potential Task Assignments within the scope of this position1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation2. Maintains a professional working relationship with internal & external customer and support staff3. Participates and leads cross-functional teams.4. Provides technical support on components, material methods, systems and equipment.5. Develops physical and functional test requirements to assure specifications & regulations are met.6. Writes and approves protocols, reports and data.7. Manages testing outlined in protocols and test methods8. Manages/develops validation studies on equipment & processes9. Conducts complaints investigations10. Executes design controls11. Participate in collecting/developing and analyzing design inputs12. Understands and follows company procedures and regulatory requirements.13. Participates in and provides input to training on department & division procedures, and policies.14. Manages project planning, budgeting, scheduling and tracking.15. Plans and coordinates engineering test builds. 16. Analyzes problems in design, process and test development. Recommend/implement solutions.17. Prepares and presents oral and written project updates and technical discussions.18. Develops and implements procedures/policy.

KNOWLEDGE AND SKILLS:

1. Ability to make and present engineering decisions2. Strong interpersonal skills3. Ability to systematically manage multiple projects from initiation through closing phases. Projects include BAS and/or supplier resourced deliverables:a) Determine and communicate project deliverablesb) Develop a work breakdown structure and estimatesc) Develop a viable schedule, management plans, and scheduled) Execute and control the project through closure4. Specific specialized engineering skills such as:a) Create & critique engineering cost analysisb) Basic tooling design and drafting knowledgec) Analyze and optimize existing process and ability to create new processesd) Create, analyze and optimize manufacturing and quality systemse) Basic product, design & prototypingf) Material Scienceg) Bioengineering principles5. Ability to train, create and critique training6. Ability to apply comparative statistics7. Software application skills8. Problem solving ability9. Ability to create, review and coordinate test protocols and reports10. Ability to generate engineering proposals.11. Oral and written presentation skills12. Ability to lead cross functional teams14. Ability to manage development programs at suppliers13. Comprehensive understanding of regulatory environment14. Demonstrated ability to create and execute project plans

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15. Demonstrated Supervisory skills16. Ability to create and control a budget17. Advanced multi-project management skills18. Diverse technical background

Basic Qualifications:This position requires:• a Bachelor degree in science or engineering with 6 (six) years of engineering experience within the medical device or equivalent regulated industry OR• Master’s degree with 5 (five) years of engineering experience within the medical device or equivalent regulated industry OR The above experience must include 3 (three) years of proven and effective project management skills. 

Sr. R&D Engineer - Western Rocky Mountain Region

Overview:This position is responsible for system development and improvement along with managing projects with divisional impact.

The ideal candidate must be able to work in a team oriented, fast paced environment.

Summary of Position with General Responsibilities:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

Scope• Consultant/Division expert• Develops Innovative ideas for the organization• Division technical expert• Broad business and technical understanding• Coach/Mentor• Influences and directs others across organization• Results Oriented• Critical Decision Maker in areas of engineering and business needs• Project Leader• Networking savvy• Serve as Representative

Potential Task Assignments within the scope of this position1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation2. Maintains a professional working relationship with internal & external customer and support staff3. Participates and leads cross-functional teams.4. Provides technical support on components, material methods, systems and equipment.5. Develops physical and functional test requirements to assure specifications & regulations are met.6. Writes and approves protocols, reports and data.7. Manages testing outlined in protocols and test methods8. Manages/develops validation studies on equipment & processes9. Conducts complaints investigations10. Executes design controls

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11. Participate in collecting/developing and analyzing design inputs12. Understands and follows company procedures and regulatory requirements.13. Participates in and provides input to training on department & division procedures, and policies.14. Manages project planning, budgeting, scheduling and tracking.15. Plans and coordinates engineering test builds. 16. Analyzes problems in design, process and test development. Recommend/implement solutions.17. Prepares and presents oral and written project updates and technical discussions.18. Develops and implements procedures/policy.

KNOWLEDGE AND SKILLS:

1. Ability to make and present engineering decisions2. Strong interpersonal skills3. Ability to systematically manage multiple projects from initiation through closing phases. Projects include company and/or supplier resourced deliverables:a) Determine and communicate project deliverablesb) Develop a work breakdown structure and estimatesc) Develop a viable schedule, management plans, and scheduled) Execute and control the project through closure4. Specific specialized engineering skills such as:a) Create & critique engineering cost analysisb) Basic tooling design and drafting knowledgec) Analyze and optimize existing process and ability to create new processesd) Create, analyze and optimize manufacturing and quality systemse) Basic product, design & prototypingf) Material Scienceg) Bioengineering principles5. Ability to train, create and critique training6. Ability to apply comparative statistics7. Software application skills8. Problem solving ability9. Ability to create, review and coordinate test protocols and reports10. Ability to generate engineering proposals.11. Oral and written presentation skills12. Ability to lead cross functional teams14. Ability to manage development programs at suppliers13. Comprehensive understanding of regulatory environment14. Demonstrated ability to create and execute project plans15. Demonstrated Supervisory skills16. Ability to create and control a budget17. Advanced multi-project management skills18. Diverse technical background

Basic Qualifications:This position requires:• a Bachelor degree in science or engineering with 6 (six) years of engineering experience within the medical device or equivalent regulated industry OR• Master’s degree with 5 (five) years of engineering experience within the medical device or equivalent regulated industry OR The above experience must include 3 (three) years’ proven and effective project management skills. PROGRAM MANAGER (MEDICAL DEVICES)

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This position is responsible for the management of new product development activities within a business franchise. They have primary responsibility to deliver safe, compliant business outcomes on time. This responsibility includes: product development, cost improvement, manufacturing support, sustaining engineering, shared service groups and compliance to divisional FDA requirements. To ensure the success of their franchise, they must ensure the success of each individual or function (QA, RA, CA, Marketing, Ops and R&D) within the team they manage.

Essential Job Functions:The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

Organizes and coordinates all activity related to their product franchise or product development group. Performs managerial responsibilities for assigned team members, which may include performance reviews, selection, promotion and disciplinary recommendations.Works with cross-functional team members in support of division goals. Establishing a product development plan that includes all functional activities from concept through product discontinuation. Creates tracks and meets project schedules and budgets.Implements department and division procedures and policies relating to all aspects of the product development groups and technology teams. Assesses priorities and makes assignments to assure project and company priorities are met. Develops, with divisional managers, a strategic direction for product development groups and communicates vision to technology teams.Assures compliance with corporate and divisional procedures, policies and government regulations.Coordinates with team members and outside professionals to assure product designs and processes meet user’s needs, as well as all applicable FDA requirements. Coordinates resource allocation and balancing for technology teams. Hires and develops staff in technical roles.Identifies development needs and potential for team members and provides/recommends project assignments and training to increase expertise to meet current or future division needs.Develops the performance standards and the norms of the product development teams and assures team communication with division management.Provides timely information to divisional management on issues which will affect the division’s performance.

Basic Qualifications/REQUIREMENTS:· Bachelors Degree in a technical field plus ten years experience or equivalency in the medical device or closely related industry.· Five years experience in project management and four years in a direct supervisory/management role is preferred.· Good working knowledge of design controls, development, manufacturing, finance, administration and some knowledge of clinical requirements for medical devices required. Demonstrated positive communication and human relation skills are also required

The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

Additional Desirable Qualifications Skills and Knowledge:

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Ability to concurrently handle a variety of projects while coordinating and supporting the efforts of cross-functional team members.Ability to independently work with in-house and outside suppliers, contractors and consultants.Ability to independently work with outside medical and technical professionals.Skills in communicating with all levels of technical and operating management (both written and oral presentation skills).Skills in project management.Ability to analyze and use technical data and resources.Knowledge of the clinical environment of the products assigned to the team.Leadership and decision making skills.Ability to understand all dimensions of customer requirements.Knowledge of Business Management skills in the areas of finance, capitalization, business planning, regulatory and product development.

Physical Demands:This position is in an office environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. Bending, stooping and reaching are also frequently required. JOBS AVAILABLE IN MULTIPLE LOCATIONS:

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