Senior Production Engineer

3 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €80,000 - €100,000
**Job Overview:**We are partnering with a leading medical device company to hire a Senior Manufacturing Engineer. This role offers the opportunity to play a key part in developing and optimising advanced manufacturing processes for Class II/III medical devices, supporting business growth and ensuring compliance with international standards.**Key Responsibilities:**
  • Provide technical leadership and mentorship to engineers and technicians, ensuring stable, efficient, and compliant manufacturing operations.
  • Lead complex troubleshooting efforts for equipment, tooling, process, or material issues using problem-solving techniques.
  • Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies.
  • Own and oversee process and equipment change control activities, ensuring quality and regulatory compliance.
  • Lead the strategy, planning, and execution of equipment and process validations.
  • Guide root cause investigations for non-conformances and ensure effective corrective and preventive actions.
  • Collaborate cross-functionally on new product introductions, risk management, and technology transfers.
**Required Skills and Qualifications:**
  • Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline).
  • 6–9 years' experience in medical device or pharmaceutical manufacturing, with proven leadership and mentoring responsibilities.
  • Strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR).
  • Demonstrated expertise in process validation and change control.
  • Skilled in continuous improvement methodologies (Lean, Six Sigma – Green Belt preferred).

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