$100K - 161K a year
Lead design transfer and servicing process development for new medical device products, ensuring quality and regulatory compliance.
Bachelor's degree, 2+ years relevant manufacturing engineering experience, process and fixture development skills, supplier experience, and preferred knowledge of quality and regulatory standards.
What you will do: As a Senior NPD Manufacturing Engineer, you will support the design transfer of products from R&D to Service. In this role, you will collaborate with cross-functional teams in both technical and non-technical capacities to successfully launch servicing of new products. You will also be responsible for developing and qualifying the repair process for medical devices at Stryker. • Use latest engineering techniques to provide design and process inputs for serviceability whilst adhering to regulatory requirements, project deadlines and product costs. • Analyze, determine, and advocate for service model that best meets the needs of our customers and business. • With minimal guidance determine and develop approaches to a variety of technical problems of complex scope and complexity. • Build productive internal and external working relationships and may periodically provide guidance and train other team members. • Lead engineer for launching servicing of new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product and service development procedures. • Ensure quality of process and product as defined in the appropriate operation and material specifications. • Provide input on components and equipment based on analysis of specifications, reliability and servicing requirements. Work with quality engineers to develop component specific testing and inspection protocols. • Analyze equipment and process to establish servicing parameters and criteria. Lead and/or participate in process review meetings. • Participate in PFMEA, Control Plan, SOP and PPAP generation associated with service product transfers and launches. • Execute, review and approve complex validation of new equipment or new processes. • Introduce new service manufacturing technology and service commercial offerings • Work closely with service sustaining to transfer engineering test procedures to manufacturing test procedures • Ensure adherence to GMP and safety procedures. What You Need: • Bachelor’s Degree, required • 2+ years of relevant experience, required • Experience with process and fixture development • Experience working with suppliers Preferred Qualifications: • Bachelor’s in Engineering • Knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO13485, ISO9001, etc. • Experience in independently executing moderately complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design. • Solid analytical skills, ability to plan, organize and implement concurrent tasks. • Proven ability to handle multiple assignments at once while meeting all deadlines • Must be able to routinely make decisions which affect immediate operations. • Demonstrated ability to plan, track and facilitate projects. • Preferred understanding of Quality Management System tools, Six Sigma tools, problem solving, root cause analysis, Lean and continuous improvement methodologies, with proven ability to apply them. $100,400 - $160,800 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
This job posting was last updated on 9/2/2025