Staff Product Safety Engineer

Stryker Group; Portage (MI); Hybrid; USD 89,000 - 149,000; Full time

Benefits offered by this job

Hybrid work model

In-office 4 days/week (Portage, MI)

Job summary

Stryker in Portage, MI seeks a Staff Product Safety Engineer to lead safety initiatives for new and existing medical devices in the Ortho Tech Orthopaedic Instruments business. You will guide product safety and regulatory compliance across the full product lifecycle.

You will collaborate with R&D and manufacturing teams, applying 60601 knowledge and safety testing to ensure robust device safety and regulatory approvals. Portage hybrid role with in-office presence four days a week.

Qualifications

• 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.

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.

Skills

Product safety

Electrical testing

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Electrical Engineering or Biomedical Engineering

Tools

Electrical testing equipment

Job description

Why Engineering at Stryker?

At Stryker, we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team:

https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

Check out our portfolio: Orthopaedic Instruments

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.

What You Will Do

• 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.

What You Need (Required Qualifications)

• 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

Preferred Qualifications

• 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

This role is hybrid in Portage, MI with the expectation to be in office 4 days a week.

$89,300 - $148,800 USD Annual