Staff Product Safety Engineer

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

Benefits offered by this job

Health benefits

401(k) plan

Employee stock purchase plan (ESPP)

Stock purchase plan

Job summary

Stryker is seeking a Staff Product Safety Engineer to lead safety initiatives for the Ortho Tech Orthopaedic Instruments (OI) line. You will guide safety practices across the product lifecycle, ensure compliance with 60601 and other safety standards, and partner with R&D to implement robust safety designs.

The role is hybrid in Portage, MI, with four in-office days per week, and requires coordinating with cross-functional teams, external labs, and regulatory agencies to achieve timely

Qualifications

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

Responsibilities

• Lead product safety activities for new product development and engineering teams.
• Define and implement product safety program plans for large development programs.
• Support regulatory compliance and safety testing across the product lifecycle.
• Interface with NRTL bodies (CSA, UL, ETL, TUV) and labs for certifications.

Skills

Safety testing

Education

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

Tools

EMI/EMC testing equipment

Regulatory labs coordination

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 conceptsExperience 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

Health benefits include:

• Medical and prescription drug insurance
• dental insurance
• vision insurance
• critical illness insurance
• accident insurance
• hospital indemnity insurance
• personalized healthcare support
• wellbeing program
• tobacco cessation program
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• basic life and AD&D insurance
• short-term disability insurance

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.