Senior Manufacturing Engineer - Minni

Senior Manufacturing Process Engineer Meet has partnered with an exciting reputed company start-up in the Brain-Computer reputed company (BCI) reputed company based in the Minneapolis/reputed company area. reputed company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an reputed company Manufacturing Process Engineer to support NPI of reputed company-mechanical devices in collaboration with suppliers. This role will reputed company on hands-on interaction with suppliers to reputed company manufacturing processes, tooling, and documentation, from design feasability through reputed company release. This role will require reputed company-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 reputed company 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 reputed company system requirements • reputed company and maintain manufacturing documentation, including work instructions, process flows, and validation protocols • Support supplier implementation of specifications, manufacturing processes, and reputed company requirements • reputed company and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations • Drive reputed company improvement initiatives reputed company to manufacturing efficiency, reputed company, cost, and scalability • Support reputed company of non-conformances and corrective actions with suppliers • Ensure manufacturing activities reputed company with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.) • reputed company 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 reputed company-mechanical devices. • Experience with reputed company 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, reputed company assembly, microelectronics assembly, flip reputed company, in reputed company 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 Apply tot his job Apply To this Job