Staff Manufacturing Engineer

Staff Manufacturing Engineer

The Staff Manufacturing Engineer provides manufacturing engineering leadership supporting the development, commercialization, and production of medical devices. This role oversees a portfolio of products manufactured primarily by contract manufacturers and drives improvements in cost, lead time, manufacturability, and overall operational performance.

The position collaborates cross-functionally with Product Development, Sustaining Engineering, Quality, Supply Chain, and external manufacturing partners to ensure robust manufacturing processes and scalable production.

Essential Duties and Responsibilities

1. Operate as a primary manufacturing technical resource for product development and lead manufacturing initiatives focused on cost reduction, lead time improvement, yield enhancement, and process robustness at contract manufacturers.
2. Define and drive manufacturing strategies across the product portfolio to improve cost, scalability, and operational performance.
3. Support the identification, technical evaluation, and relationship management of external manufacturing partners for complex medical devices.
4. Lead technical design reviews and specification transfer from R&D to internal and external suppliers, ensuring cost-effective manufacturability and inspection through DFM, DFI, and DFA principles.
5. Serve as the technical authority for design transfer and new product introduction (NPI), ensuring successful transition from development to production.
6. Lead manufacturing process development and validation activities (IQ/OQ/PQ) for new and existing products.
7. Partner with internal teams and external suppliers to resolve manufacturing issues and drive improvements in process capability, yield, and throughput.
8. Establish technical standards within the engineering organization and mentor junior engineers.
9. Lead and participate in Failure Mode and Effects Analysis (FMEA) to mitigate risks to product quality and patient safety.
10. Lead investigations into nonconformances and implement corrective and preventive actions (CAPA).
11. Analyze manufacturing data to identify trends and drive continuous improvement initiatives.
12. Develop and maintain work instructions and documentation for manufacturing processes.
13. Other duties as assigned.