Staff Product Safety Engineer

About the role

Stryker is looking for a Staff Product Safety Engineer to lead safety initiatives for new and existing products in its Ortho Tech Orthopaedic Instruments (OI) business. The role drives the strategic vision of the Product Safety organization and ensures consistent safety practices and compliance with safety and regulatory standards throughout the product lifecycle. It is hybrid in Portage, MI, with an expectation of being in the office 4 days a week.

Key responsibilities

• Support product safety activities for New Product Development and Product Engineering teams to ensure compliance with global safety requirements.
• Work with R&D teams to define and implement product safety program plans for large, complex development programs.
• Represent and advance the interests of the product safety community across the division, including technical and organizational initiatives.
• Help product development teams understand 60601 and other required safety standards during design and development of medical devices.
• Influence R&D project teams to comply with product safety standards and collaborate on design analysis within safety boundaries.
• Partner with R&D on identifying problems and solutions, and on implementing design elements relevant to product safety.
• Conduct, coordinate and evaluate safety testing results, including EMI/EMC and wireless testing.
• Act as the interface between development teams and NRTLs (e.g. CSA, UL, ETL, TUV) or other regulatory agencies.

Required profile

• Bachelor's degree in Electrical Engineering, Biomedical Engineering or a related discipline.
• 4+ years of work experience.
• 2+ years of experience in product safety.

Required skills

• Preferred: working knowledge of medical device regulations and standards (60601).
• Preferred: experience with medical device safety testing, electrical testing equipment and processes, and supporting internal and external audits.
• Preferred: knowledge of basic electrical circuits and EMC testing concepts, and experience with industry standards for product safety testing.
• Preferred: experience driving global wireless regulatory approvals (e.g. FCC/ISED/CE RED), including test planning, documentation and coordination with external labs.
• Preferred: participation in an active Certified Test Facility (CTF) program with CSA, UL or ETL.

What we offer

• Salary of $89,300 - $148,800 USD per year.
• Hybrid work in Portage, MI, with 10% travel expected.