We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
1. Process development and value engineering including PFMEA
2. Process Characterisation
3. Process Qualification/Validation
4. Planning of key deliverables into action plans with the help of the Project Manager
5. Regular reporting on the status, performance and risks of your process / technology
6. Participate in DFM reviews with Design Team to minimize lifecycle cost
7. Minimise Environmental and Health & Safety effects of your work
8. Adhere to the company’s procedures as detailed in the SOP manual
9. Support Regulatory Affairs with product submissions
10. All other duties as directed by direct manager
Education & Experience
1. Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
2. 1-3 years’ experience in product / process development with Class II / III medical devices or another regulated environment.
3. Self-motivated, with focus on Quality, Delivery and Cost.
4. Proven Root Cause analysis and problem-solving techniques (A3, 8D, TRIZ or equivalent).
1. Certified Project Management qualifications (IPMA or similar)
2. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
3. Certified Six Sigma qualifications.
4. Knowledge of anatomy and physiology.
- Innovative ‘fail fast’ environment
- Strong team environment
- Exposure to leading technology
- Travel opportunities
- Remote working where suitable
- Flexible on-site hours (Half day on Fridays)
- Spend up to 10% of your time on other initiatives – e.g. CSR, CPD, Environmental, etc.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480