Job Description
Senior Manufacturing Process Engineer
Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the Minneapolis/St. Paul 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 supplier sites frequently
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