Principal Product Safety Engineer

As Principal Product Safety Engineer, you will lead safety initiatives for new and existing products for our Ortho Tech Orthopedic Instruments 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 4 days a week.

• Own, lead and drive 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.
• Lead Product safety activities to represent and advance the interests of the product safety community across the division, including both technical and organizational initiatives.
• Lead and drive initiatives for product development teams with the technical understanding of the required safety standards during the design & development of medical devices.
• Mentor and positively influence the product safety team in safety and compliance standards.
• Lead 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.
• Navigate and influence the Intellectual landscape for filings and protection.
• Conduct, coordinate and evaluate test results for safety testing, including EMI/EMC and Wireless.
• Serve as an interface between development teams and NRTLs (e.g. CSA, UL, ETL, TUV) or other regulatory agencies.
• Support Stryker's International Initiatives and work with Regulatory to launch products in Global Markets (such as Asia-Pacific, European Union and South America).

Required Qualifications:

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related discipline
• 8+ years of work experience in the field of product safety
• 3+ years of work experience in electrical engineering

• Working knowledge of regulations and standards related to Medical (60601) products.
• Understanding of IEC standards and understanding of compliance or related regulatory compliance standards.
• Knowledge of basic electrical circuits and basic EMC testing concepts
• Medical devices safety testing experience