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. Planning and execution of verification and validation activities, including:
• Generation of Validation Protocols and Reports.
• Execution of Equipment Validations (IQs/OQs) and subsequently Process Validation (OQ / PQs).
2. Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams.
3. Provide design for manufacturing technical input to global design groups to minimise lifecycle cost.
4. Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners.
5. Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
6. Deliver stable manufacturing solutions in line with stability metrics process.
7. Management of R&D test parts and sample requests.
8. Conduct detailed product design reviews
9. Development of advanced manufacturing processes to lean guidelines
10. Manage risk management and validation lifecycle for new process or process changes.
11. Direct PFMEA studies and lead risk assessment effort for overall process
12. Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk
Education & Experience
1. Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
2. Experience in product / process development, ideally in Class II / III medical devices.
1. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
2. Proficiency of GD&T and ASME Y14.5M 1994 standards
3. Knowledge of manufacturing processes.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480