Process Development Engineer Leader

3 days ago

Galway, Galway, Ireland beBeeEngineering Full time €90,000 - €110,000
Senior Process Development Engineer

We are seeking a Senior Process Development Engineer to lead the development and implementation of manufacturing processes within our facility. This key role will work closely with cross-functional teams to ensure process design, specifications, and qualification meet all requirements.

Key Responsibilities:
  • Design and conduct engineering bench testing to investigate and develop appropriate manufacturing processes and specifications.
  • Develop and execute test methods for process qualification (validation) testing of manufacturing processes.
  • Manage sub-contract manufacturing partners through process qualification (validation) testing and during manufacturing scale-up activities.
  • Lead CAPA and NCR investigations from internal manufacturing and sub-contract manufacturing processes.
  • Provide guidance to R&D Engineers, Technicians, and Product Builders on process development and validation.
Requirements:
  • Minimum level 8 degree in Engineering or a related technical field.
  • At least 5 years of previous related experience in the medical device industry.
  • Experience in product development and process validation processes.
  • Excellent knowledge of catheter technologies, including manufacturing of reinforced (braided and coiled), steerable polymer shafts.
  • Demonstrated analytical problem-solving abilities.
  • Good working knowledge of medical device materials and processes.
  • Strong interpersonal and organizational skills and the ability to work effectively as a team member.

This is an excellent opportunity to leverage your expertise and contribute to the success of our organization.

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