Senior Process Development Specialist

4 days ago

Galway, Galway, Ireland beBeeProcessDevelopmentEngineer Full time €90,000 - €120,000

Process Development Engineer Position

We are seeking an experienced Process Development Engineer to fill a key role in transferring, implementing, validating and scaling up manufacturing processes within the facility.

The ideal candidate will have experience in product development and process validation processes, particularly in the medical device industry. They will be responsible for designing and conducting engineering bench testing, planning and developing test methods for process qualification, and managing sub-contract manufacturing partners.

A degree in Engineering or a related technical field is required, as well as at least 5 years of previous experience in the medical device industry. Strong knowledge of catheter technologies and good working knowledge of medical device materials and processes are essential.

The successful candidate will provide oversight of sub-contract manufacturing partners during routine production, scale-up and validation activities. They will also support and lead CAPA and NCR investigations from internal manufacturing and sub-contract manufacturing processes.

  • Design and conduct engineering bench testing as required
  • Ensure process design and specifications are robust and reproducible
  • Plan and develop test methods for process qualification
  • Manage sub-contract manufacturing partners through process qualification and manufacturing scale-up activities
  • Support and lead CAPA and NCR investigations

The ideal candidate will have strong interpersonal and organizational skills and the ability to work effectively as a team member. A good working knowledge of Microsoft Office, including MS Project or similar, is also required.

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