Senior Manufacturing Process Engineer

This role is Remote; candidates must be based in the Minneapolis–St. Paul area to support periodic in-person visits with local suppliers.

We are seeking a Senior Manufacturing Process Engineer to support the development and commercialization of an active implantable medical device being developed by a stealth-stage medical technology company. This role will focus on developing and scaling manufacturing processes across a distributed supplier network, supporting the transition from development through validation, clinical builds, and commercial release.

This position requires hands‑on collaboration with external manufacturing partners and internal engineering teams to ensure design intent is translated into robust, scalable, and compliant manufacturing processes. The engineer will play a key role in process development, validation, documentation, supplier technical support, and continuous improvement initiatives.

• 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)

• Bachelor’s degree in Engineering or related technical discipline
• 10+ years of medical device manufacturing experience, preferably within startup or early-stage environments
• Experience supporting implantable or electro‑mechanical medical devices strongly preferred
• Experience with manufacturing processes such as molding, laser welding, cleanroom assembly, packaging, labeling, and sterilization
• Experience with electronics manufacturing including PCB fabrication, assembly, microelectronics, and functional testing
• Experience defining and executing process validation activities
• Experience working closely with contract manufacturers and external suppliers
• Strong understanding of FDA and international medical device manufacturing and quality requirements
• Experience with manufacturing tools and systems such as Solid Works, LabVIEW, or similar automation and test platforms preferred

• Strong problem‑solving skills and ability to work in a fast‑paced, dynamic environment
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively across cross‑functional teams
• Willingness and ability to travel frequently to supplier locations