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Leading Medical Device Manufacturing Process Improvement
2 weeks ago
This is a challenging opportunity for an experienced manufacturing professional to lead the development and optimization of advanced manufacturing processes for Class II/III medical devices.
The successful candidate will be responsible for providing technical leadership and mentorship to engineers and technicians, as well as leading complex troubleshooting efforts using advanced problem-solving techniques.
Additionally, they will drive continuous improvement initiatives using Lean, Six Sigma, and other structured methodologies, own and oversee process and equipment change control activities, and lead the strategy, planning, and execution of equipment and process validations (IQ, OQ, PQ).
Requirements- Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical or related discipline)
- 6–9 years' experience in medical device or pharmaceutical manufacturing
- Strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR)
- Demonstrated expertise in process validation (IQ/OQ/PQ) and change control
- Opportunity to work on cutting-edge MedTech manufacturing processes
- Career development with leadership exposure and cross-functional project ownership
