Stryker ยท 21 hours ago
Principal Product Safety Engineer
Portage, Michigan
Full-time
Hybrid
Lead/Staff
8+ years expStryker is a leading medical technology company, and they are seeking a Principal Product Safety Engineer to lead safety initiatives for their Ortho Tech Orthopedic Instruments business. This role involves collaborating with cross-functional leadership to ensure compliance with safety and regulatory standards throughout the product lifecycle.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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)
Qualification
Required
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
Preferred
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
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase