Job Details

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