Process Development Engineer
Summary
Develop and industrialize manufacturing processes for medical devices at external suppliers, leading validation and process characterization to support product launches.
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.
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.
United States of America Pay Ranges:
US15: $102,700 - $171,100 USD Annual