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.

• 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.

• Strong knowledge of manufacturing processes (e.g., machining, injection molding, fabrication, secondary/finishing operations, and assembly) and their application in the production of medical devices.
• Strong knowledge of quality systems, inspection standards, equipment, and best practices.
• Strong experience with the creation, review, and analysis of engineering design specifications and the application of Design for Manufacturability (DFM), Design for Inspection (DFI), and Design for Assembly (DFA).
• Proficient with CAD software (e.g., Solid Works).
• Strong analytical thinking and problem-solving skills, with the ability to communicate technical concepts clearly to both technical and non-technical audiences.
• Demonstrated success working cross-functionally with R&D, Quality, Regulatory, Marketing, and Operations teams.
• Strong knowledge of engineering materials and their applications, particularly metals and plastics used in medical device manufacturing, with preferred knowledge of composite materials.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.
• Strong knowledge of FDA regulations and quality standards (21 CFR Part 820, GMP, ISO 13485, ISO 9001, ISO 14971).
• Highly proficient with statistical methods and quality tools such as SPC, Gage R‑R, and Design of Experiments (DOE).
• Demonstrated experience working with contract manufacturers and suppliers to develop, validate, and improve manufacturing processes.
• Expert knowledge in the interpretation and application of Geometric Dimensioning and Tolerancing (GD&T).
• Strong verbal, written, and organizational communication skills with the ability to operate effectively in a dynamic environment.
• Required to travel domestically up to 20% annually. Potential for international travel.

• Bachelor's degree in Engineering (Mechanical/Manufacturing, or related field)
• 10+ years of experience in manufacturing or…