Advanced Medical Device Manufacturing Specialist

2 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €75,000 - €90,000
Senior Manufacturing Engineer

We are seeking a seasoned Senior Manufacturing Engineer to join our team. As a key member of the manufacturing department, you will be responsible for developing and optimizing advanced manufacturing techniques for Class II/III medical devices.

The ideal candidate will possess a strong technical background, excellent leadership skills, and the ability to drive stable, efficient, and compliant manufacturing operations. You will provide technical guidance and mentorship to engineers and technicians, lead complex troubleshooting efforts, and drive continuous improvement initiatives.

In this role, you will also oversee process and equipment change control activities, ensure quality and regulatory compliance, and represent the manufacturing engineering department in audits and regulatory inspections.

To succeed in this position, you will need a Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline) and 6-9 years' experience in medical device or pharmaceutical manufacturing with proven leadership and mentoring responsibilities.

You will have strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR), demonstrated expertise in process validation (IQ/OQ/PQ) and change control, and skilled in continuous improvement methodologies (Lean, Six Sigma - Green Belt preferred).

Key Responsibilities:
  • Develop and optimize advanced manufacturing techniques for Class II/III medical devices
  • Provide technical guidance and mentorship to engineers and technicians
  • Lead complex troubleshooting efforts and drive continuous improvement initiatives
  • Oversee process and equipment change control activities and ensure quality and regulatory compliance
  • Represent the manufacturing engineering department in audits and regulatory inspections

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