Senior Manufacturing Process Development Professional

2 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €90,000 - €120,000
Advanced Manufacturing Process Specialist

This is an exciting opportunity to play a key part in developing and optimizing advanced manufacturing processes for Class II/III medical devices.

Main 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 advanced problem-solving techniques.
  • Drive continuous improvement initiatives using structured methodologies such as Lean and Six Sigma.
  • 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 (IQ, OQ, PQ).
  • Guide root cause investigations for non-conformances and ensure effective corrective and preventive actions (CAPA).
  • Collaborate cross-functionally on new product introductions, risk management, and technology transfers.
  • Represent manufacturing engineering in audits and regulatory inspections, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR.
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 (IQ/OQ/PQ) and change control.
  • Skillled in continuous improvement methodologies (Lean, Six Sigma – Green Belt preferred).
What We Offer:
  • Opportunity to work on cutting-edge MedTech manufacturing processes.
  • Career development with leadership exposure and cross-functional project ownership.
  • A competitive salary and benefits package.
  • A collaborative and innovative team environment.

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