Advanced Medical Device Manufacturing Professional

14 hours ago

Galway, Galway, Ireland beBeeManufacturing Full time €70,000 - €90,000
Senior Manufacturing Engineer Role

We are seeking a highly skilled Senior Manufacturing Engineer to join our team. This role offers the opportunity to play a key part in developing and optimizing advanced manufacturing processes for Class II/III medical devices, supporting business growth and ensuring compliance with the highest international standards.

This position is ideal for an experienced engineer with strong leadership skills, a passion for continuous improvement, and a proven track record in medical device manufacturing.

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 advanced problem-solving techniques.
  • Drive continuous improvement initiatives using Lean, Six Sigma, and other structured 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 (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 (e.g. FMEAs), 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.
  • Skilled in continuous improvement methodologies (Lean, Six Sigma – Green Belt preferred).
Benefits:
  • Opportunity to work on cutting-edge MedTech manufacturing processes.
  • Career development with leadership exposure and cross-functional project ownership.
  • Competitive salary and benefits package.
  • Collaborative and innovative team environment.

Please note that we can only respond to candidates whose qualifications closely match the specific requirements of the role. We genuinely value your interest in this opportunity and thank you for your understanding.

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