Location: Osseo, MN
Description: Job Title:
Senior / Principal Process Development Engineer - Balloon CatheterLocation: Summary:A senior-level process development engineer role focused on the development, scale-up, validation, and transfer of balloon catheter manufacturing processes from early feasibility through commercial production. The position serves as a technical leader and subject-matter expert for balloon catheter technologies, working cross-functionally with design engineering, operations, quality, suppliers, and clients to deliver robust, scalable, and compliant manufacturing solutions. The role combines hands-on engineering, equipment development, automation exposure, and technical leadership within a regulated medical device environment.
Required / Mandatory Skills:- Hands-on balloon catheter process development and manufacturing experience
- Balloon forming, bonding, shaft assembly, tipping, welding, and secondary operations
- Design for Manufacturability (DFM) collaboration with product/design engineering
- Process development, optimization, and scale-up from prototype to production transfer
- Equipment and process specification development (URS, equipment specs, process flows)
- FAT, SAT, IQ, OQ, PQ, and process characterization execution
- Statistical tools: DOE, SPC, capability studies, hypothesis testing
- Medical device regulated manufacturing experience (ISO 13485, FDA QSR)
- Cross-functional technical project leadership
- Technical documentation (protocols, reports, risk assessments, work instructions)
Qualification:- Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related discipline
- 10+ years of medical device experience with significant balloon catheter process development exposure
- Experience with balloon catheter materials such as PET, Nylon, and Pebax
- Background in extrusion, injection molding, precision components, and catheter assembly
- Master's Degree in Engineering (preferred)
- Experience with automation in catheter manufacturing (preferred)
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