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. Execution and project management responsibility for packaging aspects of NPI and Tech development projects.
2. Manage risk management and validation lifecycle for new process or process changes.
3. Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ).
4. Conduct engineering studies to ensure compliance
5. Direct PFMEA studies and lead risk assessment effort for overall process.
6. Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk
7. Design, develop and source tools, fixtures and special equipment for pack processes. Co-ordinate with internal and external partners.
8. Planning of key deliverables into action plans & provide timely and accurate reporting on project activities.
9. Represent the Operations team on product development projects, communicating requirements and proposing solutions.
10. Conduct detailed product design reviews - Manufacturing technical expert to global design groups.
11. Deliver stable manufacturing solutions in line with stability metrics process.
12. Development of advanced manufacturing processes to lean guidelines.

Education & Experience

1. A minimum of a Bachelor’s degree in Engineering is required. A Masters or PhD is an advantage.
2. Demonstrated validation experience
3. At least 3 years experience in Medical Devices or regulated industry and exhibiting evidence of GDP and technical writing

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.