Senior Manufacturing Engineer
- Galway
- Permanent
- Full-time
- 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.
- 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).
- 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.