Process Development Engineer I-II

Description:

Job Title: Senior / Principal Process Development Engineer - Balloon Catheter

Location:

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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Contact:

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