Staff Product Safety Engineer

Stryker•Portage, MI

12d•$89,300 - $148,800•Hybrid

About The Position

As Staff Product Safety Engineer, you will lead safety initiatives for new and existing products for our Ortho Tech Orthopaedic Instruments (OI) 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.

Requirements

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

Nice To Haves

Working knowledge of regulations and standards related to Medical (60601) products
Medical devices safety testing experience
Demonstrated expertise in electrical testing equipment and processes
Experience in supporting internal and external audits
Knowledge of basic electrical circuits and basic EMC testing concepts
Experience with accepted industry standards for product safety testing
Experience driving global wireless regulatory approvals/registrations (e.g., FCC/ISED/CE RED), including test planning, documentation, and coordination with external labs/certification bodies
Participation in an active Certified Test Facility (CTF) program with CSA, UL, or ETL

Responsibilities

Support product safety activities for New Product Development and 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 to 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.
Conduct, coordinate and evaluate results of 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.