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. Technical execution of process development activities relating to clean and packaging aspects of NPI and technology development projects.
2. Manage risk management and validation lifecycle for new process or process changes.
3. Direct PFMEA studies and lead risk assessment effort for overall process.
4. Influence innovative qualification and validation techniques based on statistical assessment, failure model and overall risk .
5. Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ/SMA).
6. Conduct engineering studies to ensure compliance.
7. Design, develop and source tools, fixtures and special equipment for clean and pack processes.
8. Liaise with supplier quality to complete supplier product and process verification process for pack components
9. Planning of key deliverables into action plans & provide timely and accurate reporting on project activities.
10. Development of advanced manufacturing processes guided by six sigma principles.
11. Represent the Operations team on product development projects, communicating requirements and proposing solutions.
12. Deliver stable manufacturing solutions in line with stability metrics process.
13. Participate in DFM reviews as a manufacturing technical expert with global Design groups to minimize lifecycle cost

Education & Experience
1. A minimum of a Bachelor’s degree in Engineering is required
2. Demonstrated validation experience
3. Experience in Medical Devices or regulated industry with demonstrated GDP and technical writing skills

Desireable
1. Relevant cleaning, packaging technology and materials experience
2. Clean technology & Packaging design experience and or exposure
3. Knowledge of Transit and Stability Qualifications for terminally sterilised medical devices
4. Exposure to New Product & Process Introduction
5. Root Cause analysis and problem-solving technique
6. Six Sigma and lean manufacturing qualifications

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information