Process Development Engineer

About the role

Stryker is looking for a Process Development Engineer in Irvine to bring innovative medical devices from concept into commercial production. The role works closely with contract manufacturers, component suppliers and cross-functional teams to develop, validate and industrialize manufacturing processes that support product launches, leading technical activities across the product development lifecycle.

Key responsibilities

• Lead development of manufacturing processes at external suppliers for new product introduction programs, from concept through commercial launch.
• Design and run process characterization studies, Design of Experiments (DOE) and statistical analyses to define process capability, critical parameters and operating windows.
• Develop and coordinate manufacturing industrialization plans, including engineering builds, validation activities, readiness reviews and commercialization milestones.
• Drive supplier technical execution through technical reviews, monitoring of engineering deliverables and schedules, and resolution of manufacturing and process issues.
• Create and maintain validation and manufacturing documentation, including IQ/OQ/PQ protocols, validation reports, process flows, equipment specifications, work instructions and risk assessments.

Required profile

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering or a related engineering discipline.
• At least 5 years of engineering experience in the medical device industry.
• Experience developing manufacturing processes for new products and working directly with external suppliers or contract manufacturers.

Required skills

• Process characterization, DOE, statistical analysis and manufacturing process validation (IQ/OQ/PQ).
• Preferred: catheter-based, minimally invasive, electromechanical or similar medical device experience.
• Preferred: extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly or packaging.
• Preferred: manufacturing industrialization, technology transfer, DFM, PFMEA, APQP, PPAP, Minitab or JMP.

The position is onsite with 20% travel; the stated annual pay range is $102,700 - $171,100 USD.