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.
Duties
1. Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams.
2. Provide design for manufacturing technical input to global design groups to minimise lifecycle cost.
3. Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
4. Deliver stable manufacturing solutions in line with stability metrics process.
5. Conduct and lead detailed product design reviews.
6. Development of advanced manufacturing processes to lean guidelines.
7. Manage risk management and validation lifecycle for new process or process changes.
8. Management of the Asset Lifecycle for new equipment and processes (URS/RA/IQ/OQ/PQ).
9. Direct PFMEA studies and lead risk assessment effort for overall process.
10. Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk.
11. Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
12. Provide timely and accurate reporting on project activities.
13. All other duties as directed by direct manager.
Education & Experience
1. Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and 3 years minimum post graduate (Ideally 5 years plus) experience in a medical device or comparable hi-tech environment.
2. Proven track record in development, installation and qualification of manufacturing processes for New Products or Product Transfer.
3. Experience using proven problem solving/Root techniques (8D, TRIZ or equivalent).
4. Certification from an accredited institution in Project/Program Management.
5. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
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