Employer: Stryker Corporation
Job Title: Senior Engineer, Process Development
Job Requisition: 1006.362.4
Job Location: Portage, Michigan
Job Type: Full Time
Rate of Pay: $96,000.00 to $129,500.00 per Year
Duties: Provide engineering support for new products and process introductions, launching new medical device manufacturing processes across internal and external sites. Ensure quality of process and product through adherence to FDA CFR 21. Select components and equipment based on analysis of mechanical and electrical specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Maintain budget for equipment and process development needs. Work with quality engineers to develop component specific testing and inspection protocols. Analyze equipment to establish operating data and conduct experimental test and result analysis. Lead process review meetings on complex technical problems. Conduct Gage R&R, capability studies, and measurement system analysis (MSA) for inspection systems. Create and maintain risk control documentation associated with PFMEA, Control Plan, SOP and PPAP generation for product launches. Analyze data sets for capability studies for in-process inspection and generate subsequent inspection documentation. Serve as subject matter expert (SME) in plastic welding processes, offering guidance during product transfer and validation activities. Work in a hands-on manner at the manufacturing site to lead the implementation of new processes as specified in development. Create training curriculum and lead training for manufacturing team members. Design and implement air leak testing fixtures to evaluate the hermeticity of sealed enclosures and ensure compliance with pressure decay specifications. Creating fastener torque settings and tooling for sealed electronics enclosure. Procurement and set up of production line equipment like benches, racks, facilities/utility updates, custom tooling and equipment. Ensure adherence to GMP and safety procedures related to manufacturing environment. Review and approve validation documentation.
Position requires approximately 15% domestic and/or international travel.
Requirements: Must have a Bachelor’s degree in Electrical Engineering, Electronics Engineering or Mechanical Engineering and two (2) of experience in manufacturing engineering and process development. Experience collaborating with cross-functional partners, including Quality, Sourcing, R&D, Regulatory, and Operations, to drive process development, ensure design transfer readiness, and support successful product launch; experience with ultrasonic and laser welding of plastic components; experience operating in a controlled production environment with adherence to environmental health and safety standards; experience executing process validations (IQ, OQ, PQ); experience using statistical analysis software to perform Design of Experiments (DOE), analyze manufacturing trends, and evaluate process capability for decision-making in a production environment; experience applying PFMEA to identify process risks, developing control plans for manufacturing operations, conducting DOE to optimize key parameters, and using SPC methods to monitor and improve process stability; and experience working under FDA regulations or comparable international regulatory frameworks such as ISO 13485, EU MDR, or equivalent, with a focus on ensuring process compliance during development, validation, and production launch activities.
Contact: To apply contact [email protected].?Must reference job 1006.362.4.
