As Staff Product Safety Engineer, you will lead safety initiatives for new and existing products for our Instruments Interventional Spine (IVS) business. Collaborating with cross-functional leadership, you'll drive the strategic vision of the Product Safety organization, ensuring consistent safety practices throughout the product lifecycle. This role is responsible for product safety and compliance, providing guidance and solutions to meet safety and regulatory standards for successful medical device design.
This role is hybrid in Portage, MI with the expectation to be in office 3-4 days a week.
Check out our product portfolio: Stryker IVS
What you will do:
• Support product safety activities for New Product Development, Product Engineering teams to ensure compliance of our products to the global safety requirements.
• Work with R&D teams to define and implement a product safety program plans for large, complex development programs.
• Participate in product safety activities to represent and advance the interests of the product safety community across the division, including both technical and organizational initiatives.
• Support initiatives for product development teams with the technical understanding of 60601 and other required safety standards during the design & development of medical devices.
• Positively influence the R&D project teams to ensure compliance for the product safety standards.
• Collaborate with the team on design analysis to support the development of products within the boundaries of safety standards.
• Partner with R&D on identification of problems and solutions, analysis, and implementation of design elements relevant for product safety.
What you need:
Required Qualifications:
• Bachelor's degree in Electrical Engineering , Biomedical Engineering, Mechanical Engineering or related discipline
• 4+ years of work experience
• 2+ years of work experience in the field of product safety.
Preferred Qualifications:
• Electrical Engineering experience
• Working knowledge of regulations and standards related to Medical (60601) products
• Experience in supporting internal and external audits
• Knowledge of basic electrical circuits and basic EMC testing concepts
• Medical devices safety testing experience
• Experience with accepted industry standards for product safety testing