Medical Device Manufacturing Engineer

5 hours ago

Galway, Galway, Ireland beBeeManufacturing Full time €72,000 - €108,000
Process Development Specialist

Our innovative team is seeking an accomplished Process Development Specialist to join their ranks. As a key member of our product development team, you will be responsible for developing manufacturing processes, materials, and methods.

The ideal candidate will have a proven track record in process development, with a strong background in polymer, mechanical, manufacturing, or biomedical engineering. Experience in fabrication and manufacture of catheter-based medical devices, preferably with large calibre delivery systems, is highly desirable.

Key Responsibilities:

  • Design, specify, procure, and qualify process fixtures and equipment.
  • Develop Work Instructions and other supporting documentation for manufacturing processes.
  • Execute process characterisation and validation activities.
  • Build Quality into work by maintaining compliance to all quality requirements.
  • Work with internal cross-functional teams and contract manufacturers to ensure system design meets design input.
  • Evaluate relevant process and manufacturing technologies to identify opportunities for implementation.

Requirements:

  • Minimum three years of medical device development experience with a primary or Master's Degree in polymer, mechanical, manufacturing, or biomedical engineering.
  • Product and process development skills in medical devices, particularly in fixture and equipment design, process validation, and Work Instructions development.

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