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
• 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. • Define and drive manufacturing strategies across the product portfolio to improve cost, scalability, and operational performance. • Support the identification, technical evaluation, and relationship management of external manufacturing partners for complex medical devices. • 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. • Serve as the technical authority for design transfer and new product introduction (NPI), ensuring successful transition from development to production. • Lead manufacturing process development and validation activities (IQ/OQ/PQ) for new and existing products. • Partner with internal teams and external suppliers to resolve manufacturing issues and drive improvements in process capability, yield, and throughput. • Establish technical standards within the engineering organization and mentor junior engineers. • Lead and participate in Failure Mode and Effects Analysis (FMEA) to mitigate risks to product quality and patient safety. • Lead investigations into nonconformances and implement corrective and preventive actions (CAPA). • Analyze manufacturing data to identify trends and drive continuous improvement initiatives. • Develop and maintain work instructions and documentation for manufacturing processes. • Other duties as assigned.