Process Development Engineer
Stryker
Summary
Join a team focused on bringing innovative medical devices from concept into commercial production through strong manufacturing execution and supplier collaboration. In this role, you will work closely with contract manufacturers, component suppliers, and cross-functional teams to develop, validate, and industrialize manufacturing processes that support successful product launches. This position offers the opportunity to lead technical activities across the product development lifecycle while driving manufacturing readiness at external production partners.
Job description
What You Will Do
- Lead development of manufacturing processes at external suppliers for new product introduction programs, from concept through commercial launch.
- Design and execute process characterization studies, Design of Experiments (DOE), and statistical analyses to establish 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 by leading technical reviews, monitoring engineering deliverables and schedules, and resolving manufacturing and process-related issues.
- Create and maintain validation and manufacturing documentation, including IQ/OQ/PQ protocols, validation reports, process flows, equipment specifications, work instructions, and risk assessments.
What You Will Need
Required:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
- Minimum 5 years of engineering experience within the medical device industry.
- Experience developing manufacturing processes for new products.
- Experience working directly with external suppliers or contract manufacturers.
- Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation (IQ/OQ/PQ).
Preferred:
- Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products.
- Experience with manufacturing technologies such as extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging.
- Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP.
Requirements
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
- Minimum 5 years of engineering experience within the medical device industry.
- Experience developing manufacturing processes for new products.
- Experience working directly with external suppliers or contract manufacturers.
- Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation (IQ/OQ/PQ).
- Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products.
- Experience with manufacturing technologies such as extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging.
- Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP.
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.