Advanced Medical Device Production Specialist
4 days ago
This is a Senior Manufacturing Engineer position with a leading medical device company. The successful candidate will play a key part in developing and optimising advanced manufacturing processes for Class II/III medical devices, supporting business growth and ensuring compliance with the highest 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 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).
We are a collaborative and innovative team environment that offers career development with leadership exposure and cross-functional project ownership. We value your interest in this opportunity and thank you for your understanding.
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