Senior Manufacturing Process Engineer (Sunnyvale)

Senior Manufacturing Process Engineer Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the San Francisco Bay area. The company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an experienced Manufacturing Process Engineer to support NPI of electro-mechanical devices in collaboration with suppliers.

This role will focus on hands-on interaction with suppliers to develop manufacturing processes, tooling, and documentation, from design feasability through commercial release. This role will require real-time engagement and technical support of suppliers, and this individual will be expected to travel often to domestic supplier sites and occasionally to international suppliers.

Primary Responsibilities: Serve as the primary technical liaison to external manufacturing partners, ensuring successful delivery of components, assemblies, and finished devices Collaborate with product development teams to ensure designs are manufacturable and compliant with medical device quality system requirements Develop and maintain manufacturing documentation, including work instructions, process flows, and validation protocols Support supplier implementation of specifications, manufacturing processes, and quality requirements Lead and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations Drive continuous improvement initiatives related to manufacturing efficiency, quality, cost, and scalability Support resolution of non-conformances and corrective actions with suppliers Ensure manufacturing activities comply with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.) Provide hands-on technical support to suppliers, including travel as needed (domestic and international)

Role Requirements: B.S. in relevant engineering discipline, or equivalent experience. 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices. Experience with active implantable systems (Implant, Leads, Externals, etc.). Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization. Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test. Experience with manufacturing automation. Experience in defining and executing process validation activities. Experience collaborating with internal customers and external partners. Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements. Experience with Solidworks, Labview / manufacturing process and test automation software. Ability to travel to Domestic and International supplier sites frequently