Certificate in Quality Engineering & Diploma in Professional Competence Developed for unemployed Engineers and Technicians to convert to the Medtech Sector

IMDA SPRINGBOARD 2014

IMDA Quality Engineering Programme provides new career opportunities in Medtech Sector

“ Medtech industry survey found that 81% of companies are currently hiring engineers.” DR SINÉAD KEOGH Director, IMDA

IMDA SPRINGBOARD 2015

The Irish Medical Devices Association (IMDA), the Ibec group that represents the Medical technology sector, is delighted to present its Quality Engineering programmewhich is now running for the fourth consecutive year.

The programme, funded by Springboard, is designed to provide out of work engineers and scientists with the skills to take up new work in the Medtech sector. The training takes place two days per week over 15 weeks in Limerick and is accredited by the University of Limerick and Dublin Institute of Technology. On successful completion of the training programme, the participants receive a Certificate in Quality Engineering, QQI Level 8 and a Diploma in Professional Competence, QQI Level 6.

Despite high unemployment, many medical technology companies are finding it difficult to find suitably qualified quality engineers. The IMDA skills survey, conducted in March 2014, was based on the responses of chief executives and HR officers of companies employing around 11,000 in the Irish Medtech sector. The IMDA survey found that 81% of companies are currently hiring engineers and of these;

• 59% of companies are currently hiring quality engineers and

• 62% will require additional quality engineers over the next 12 month period.

Jobseeker InformationA Career in the Hi-Tech Sector – Programme Success Rates This hugely successful programme gives engineers and science graduates the additional skills needed to help them find jobs. Over the past three years 180 jobseekers have completed the programme.

The IMDA has worked directly with more than 50 of its member companies to secure internships across most regions in Ireland (Athlone, Cork, Dublin, Galway, Limerick, Mayo, Sligo & Waterford). While an internship cannot be guaranteed, 82% of our previous course participants in 2012 and 2013 secured either an internship or full time employment in the hi-tech sector after successfully completing the programme.

Examples of just some of the careers secured by past graduates in the hi-tech sector include; quality inspector, chemist; engineer, QA /QC inspector, design engineer, quality assurance engineer, junior R&D engineer, documentation specialist, validation specialist, manufacturing engineer, quality technician and customer project manager.

“ Over the past three years, IMDA has worked directly with 50 of its member companies across most regions in Ireland; Athlone, Cork, Dublin, Galway, Limerick, Mayo, Sligo & Waterford to secure internships.” PAULINE O’FLANAGAN Springboard Manager, IMDA

A Rewarding Career Awaits - Seeking talented job seekers for the 2015 programme The thriving Medical Technology Sector is looking for 32 jobseekers to participate in the Quality Engineering for Life Sciences programme at Limerick University. IMDA Springboard can equip you with a recognised qualification and the chance for a work placement at a top medical technology company. Plus you get to keep your social welfare benefits. IMDA Springboard is free to successful candidates but places are limited. So, if you are an unemployed engineer, scientist, technician or equivalent, we would like to hear from you.

To check if you are eligible to participate in this course, please visit; http://springboardcourses.ie/eligibility

Companies – Hosting An Internship Adds ValueThe availability of suitably skilled professionals for the sector is key to the growth and development of the ecosystem here. IMDA would like to thank all their member companies who have supported this programme over the past 3 years.

Without company support, we would not be in a position to provide these valuable internships for graduates. By participating in the programme, your organisation will:

• Give an unemployed person the opportunity to gain relevant work experience• Access potential future employees• Enhance the performance of your organisation by offering an internship to motivated individuals with enthusiasm and a passion for developing their careers• Bring in fresh talent, fresh ideas and new thinking and• Access newly trained interns with recent skills sets or skilled workers that add real value to your organisation

About the Medtech sector in IrelandThe medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 27,000 people, with annual exports of €8bn. 18 of the world’s top 25 medical technology companies have a base in Ireland and 50% of the 350 Medtech companies based here are indigenous.

Over 2,300 jobs have been announced over the past three years along with a €290 million investment in the industry. The availability of key skillsets are critical to the continued growth and development of the sector in Ireland. To find out more about the sector visit www.imda.ie or www.imdaspringboard.ie

IMDA SPRINGBOARD 2015

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Pauline O’FlanaganSpringboard ManagerIMDATel: + 353 61 431802

Enda DempseyNetwork ExecutiveIMDATel: +353 1 605 1727

Michelle Reinecke-QuainNetwork AdministratorIMDATel: + 353 61 431802

Certificate in Quality Engineering& Diploma in Professional Competence

Certificate in Quality Engineering & Diploma in Professional CompetenceDeveloped specifically to enable unemployed Engineers or equivalent and Technicians of traditional disciplines to convert to the Medical Device/Pharmaceutical Sectors. Ibec’s Life Sciences members have vacancies for suitably qualified engineers and technicians.

This programme will help engineers and technicians from traditional disciplines to ‘cross over’ into the ‘newer’ realms of engineering which are often hi-tech, hi-precision and highly regulated. The Springboard accredited training is awarded by University of Limerick and Dublin Institute of Technology /Ibec to impart the requisite skills. These skills will be applied via an accredited placement in a relevant company with an agreed project. The process is supervised and supported by a mentor to ensure that the participating companies and the trainee will optimise the relationship with tangible outputs.

Programme OverviewStage Title Duration

Week 1, 2, 4, 6, 8, 10, 12, 15 Introduction, Career Development, Certificate in Quality Engineering 2 days a week

Week 3, 5, 7, 9, 11, 13, 14, 15 Diploma in Professional Competence 2 days a week

Week 9 Process validation 1 day

Week 11 & 13 Employability Skills 1 day a week

Participant ProfileThis is a golden opportunity for the right people. Completing the 2 modules is an intense and challenging experience.As class room and self study are involved a high degree of motivation will be required. The IMDA coordinator will assist all participants to make the transition from their former role through the study period, and if selected, into the 26 week JobBridge internship. The chance is there to shine. All age profiles are welcome to take part. Participants will need to have ideally a minimum educational standard of a Level 7 Degree in an engineering/technical qualification or equivalent. As there are limited places on this course, places will be allocated on a first come basis subject to assessment and interview.

CertificationSuccessful candidates will receive an individual accreditation for each module:• Dublin Institute of Technology in association with Ibec for the Diploma in Professional Competence (QQI Level 6 20 credits) • University of Limerick & Global Business Institute for the Certificate in Quality Engineering (QQI Level 8 30 credits including internship) and preparation for ASQ CQE Exam. (Candidates can sit the ASQ exam at their own time after work experience in the relevant area of knowledge).

The 2 modules and their practical application will significantly enhance the employment prospects of all the participants. The programme will also include training on CV preparation and Interviewing Skills and an accredited Career Development module.

How will this affect my Social Welfare Entitlements?During the 15 weeks directed training portion of the programme candidates will be in a position to retain any social welfare entitlements they are entitled to. If selected for a six month internship programme, eligible candidates may receive an additional allowance of €50 per week on top of their social welfare entitlements, in accordance with the eligibility criteria set out under JobBridge - the National Internship Programme. www.jobbridge.ie/InternEligible.aspx

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Certificate in Quality EngineeringUniversity of LimerickThe Certificate in Quality Engineering is a person who understands the principles of evaluation and control of product and service quality. This course is designed to cover all modules of the American Society for Quality (ASQ) in preparation for the Certified Quality Engineer’s examination.

Programme OutcomesOn successful completion of this module the learner will understand:• Management and Leadership in Quality Engineering• Quality Systems Development, Implementation, and Verification• Planning, Controlling, Assuring Product and Process Quality• Reliability and Risk Management

• Problem Solving and Quality Improvement• Quantitative Methods – Concepts of probability & statistics, Statistical decision making, Modeling of relationship between variables, Design of experiments, SPC, Reliability Analysis, Process Capability Analysis• MINITAB • Career Development

“ The Medtech sector employs over 27,000 people in Ireland which represents 6% of Europe’s Medtech workforce.” DR SINÉAD KEOGH Director, IMDA

Certificate in Quality Engineering& Diploma in Professional Competence

Diploma in Professional CompetenceIbec / Dublin Institute of TechnologyThe Diploma in Professional Competence enhances an array of soft skills that are vital in the business environment. Graduates develop their presentation and communication skills, learn the steps involved in strategic planning and practice effective collaboration methods with team members.

Programme OutcomesOn completion of this programme, participants will:

• Develop active listening and communication skills• Understand key areas of personal effectiveness such as time management, decision making and presentation skills• Develop an integrated theoretical and practical perspective on Management and Leadership• Understand fundamental principles involved in the production of company accounts and develop a capacity for interpretation and analysis of financial information

• Resolve conflict in a more assertive and collaborative manner• Understand human factors in the business environment and develop an awareness of their leadership / management style• Understand the steps involved in a formal strategic planning process and how to develop a framework of analysis to identify problems in business scenarios• Develop the critical professional skills needed to be a high performing manager and leader

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IMDA SPRINGBOARD 2015

Starting a Career at Vitalograph (Ireland) Ltd, ClareTom Healy, Regulatory Affairs and Quality Assurance Manager at Vitalograph (Ireland) Ltd, talks about the value of supporting the QA/RA Internship Programme

Vitalograph is a world leading provider of outstanding quality cardio-respiratory diagnostic devices, clinical trials and medical equipment servicing. Our extensive respiratory range includes spirometers, peak flow meters, COPD screeners, asthma monitors, e-diaries, inhaler trainers and resuscitation devices. Three of last year’s quality engineering graduates joined County Clare based Vitalograph for their work placement. The graduates spent six months with us to see if they could put their learning into practice. Even though the three people came from very diverse backgrounds and had never considered the Medtech sector previously, they all progressed to the end of their placements and we now employ two of them, whilst the third is employed in Limerick. Vitalograph created a specific in-house programme for IMDA Springboard graduates to give interns experience in raw material quality control inspection, final acceptance finished device inspection, internal system auditing, process auditing, document control, and the Corrective and Preventive Action (CAPA) programme, including management of supplier quality. We aimed to bring people to a stage of being employable in the medical device sector in a number of key areas. The three interns adapted very well to the programme and brought a different perspective to the appraisal of quality processes. One of the participants, Dominic Devereux, is now a quality inspector with Vitalograph. Prior to joining the IMDA Springboard programme, he had accumulated 18 years of practical experience in computer manufacturing but had no experience in the medical technology field.

Dominic Devereux, Quality Inspector talks about his experience as an intern at Vitalograph

The programme gave me experience in the medical technology field and I was able to show that I could adapt to a new area. The work experience was key and during the programme, you really start to appreciate how the experience you have can be applied in other areas.

Quality start with Bio Medical Research, Co Galway

John Nunan participated in the Certificate in Quality Engineering & Diploma in Management through IMDA Springboard

As part of his internship, John was assigned a mentor and was tasked with reviewing Bio-Medical Research’s (BMR) Risk Management Standard Operating Procedure in relation to the 2012 version of the Risk Management Standard ISO14971. John took on the project with great enthusiasm and he completed the task to a very high level of competency and detail. “The IMDA Springboard programme provided an opportunity to allow the company to try something with minimal impact on budget”, Conor Minogue, Technical Director, said, “There are always areas where a given project cannot be quite justified over competing projects. The company gets to test a concept it might not have done otherwise and the trainee gets some work experience. It is a win-win situation.”John Nunan said, “The Springboard courses are specifically targeted at industry sectors where there are skills shortages. The courses allow a person to re-focus their CV to better fit employer’s requirements. The internship aspect provides a way for someone out of work to demonstrate that they are motivated, focused and committed on working in their targeted area. I found the work experience part of the programme to be the most valuable, as it allowed me to develop skills in a way that cannot be taught in a classroom setting.”

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Case Studies

Following his internship, John has taken up a permanent position within the Quality team of BMR.Bio-Medical Research (BMR) Ltd. is a privately owned Irish business with headquarters in Galway. With over 40 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief, the company has established itself as a world leader in development of medical grade Electrical Muscle Stimulator (EMS) technology, and respected for the clinical trials, controlled product trials and the clinical evidence that is standard with any of their products.The company is committed to the maintenance and continuous improvement of an effective Quality Management System. With many competing projects requiring attention the IMDA Springboard offered an opportunity and resource to focus on a review of the Risk Management Standard ISO14971.

Starting a Career at Nypro Healthcare, Co Wicklow

Edward Seery, Quality Validation Engineer, Nypro Healthcare, talks about his experiences as an intern at Nypro Healthcare

On completion of my primary degree in chemical engineering I spent a number of years travelling. Last year I returned home to find a very a different economic climate to the one I had left behind in 2007. I felt I needed to give myself a competitive edge to differentiate myself from other candidates in the market, so when the IMDA Springboard Quality Engineering conversion course became available I grabbed the opportunity with both hands.The course provided me with the opportunity to develop my technical expertise in quality engineering and gain an insight into the healthcare industry. The IMDA Springboard Quality Engineering conversion course really broadened my horizons and employment opportunities, so much so that the day after completing my exams, Nypro Healthcare interviewed me for a Quality Validation Engineer position and one week later I started.

Ruth Lloyd, European Talent Manager, Nypro Healthcare, talks about the value of supporting the IMDA’s quality engineering internship programme

Nypro Ireland employs in excess of 360 staff at its manufacturing facilities located in Bray and Waterford and is the strategic European location for the Drug Delivery & Diagnostics segment within Nypro Healthcare. Our facilities in Ireland extend to over 350,000 sq ft dedicated to complex molding and high speed automated assembly of medical device and drug delivery products including clinical builds. Nypro Healthcare is the employer of choice sought by many students and interns. Nypro Healthcare provides its customers with a full suite of services from early medical device concept through to high volume production for medical device and finished pharmaceutical packaging. The ethos of Nypro Healthcare is Make A Difference and that difference is enabled and delivered by Nypro Healthcare’s focus on talent management and development. Nypro focuses on growing talent from within to support the technical needs of our business at a time where these skills are in high demand and short in supply. In addition to working with IMDA on internship programmes, we also partner with a number of universities through student placements providing six to nine month work placements. Whilst these programmes are obviously beneficial for the students and interns they also provide a great opportunity for Nypro Healthcare to identify, nurture and grow potential talent for our organisation. It is through successful partnerships with IMDA that Nypro can ensure it continues to be at the leading edge of medical device design, innovation and delivery.

IMDA SPRINGBOARD 2015

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IMDA SPRINGBOARD Gardner House, Bank Place, Charlotte Quay, Limerick

PHONE + 353 (0)61 431802 EMAIL michelle.reinecke-quain@ibec.ie

www.imdaspringboard.ie

IRISH MEDICAL DEVICES ASSOCIATION84/86 Lower Baggot Street Dublin 2

PHONE + 353 (0)1 605 1500 FAX + 353 (0)1 638 1500EMAIL info@imda.ie www.imda.ie

IMDA is a business sector within Ibec