Senior Product Safety Engineer - MedTech (Hybrid)

Stryker Corporation; Portage (MI); Hybrid; Confidential; Full time

Job summary

Stryker Corporation in Portage, MI, is seeking a Staff Product Safety Engineer to lead safety initiatives for orthopaedic instruments. You will collaborate with cross-functional teams to ensure compliance across the product lifecycle and guide design decisions toward safer medical devices.

The role requires a Bachelor's in Electrical or Biomedical Eng and several years in product safety, with experience in standards like 60601 and regulatory approvals.

Qualifications

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

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.

Education

Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related discipline

Tools

EMI/EMC testing equipment

Job description

Stryker Corporation in Portage, MI, is seeking a Staff Product Safety Engineer to lead safety initiatives for orthopaedic instruments. You will collaborate with cross-functional teams to ensure compliance across the product lifecycle and guide design decisions toward safer medical devices.

The role requires a Bachelor's in Electrical or Biomedical Eng and several years in product safety, with experience in standards like 60601 and regulatory approvals.