Staff Product Safety Engineer

Stryker • Portage, MI

3d • 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. 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.

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 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.

Benefits

• Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
• Stryker is an EO employer – M/V/D.
• Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
• Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
• We are proud to be named one of the World’s Best Workplaces!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior