Staff Product Safety Engineer

Stryker; Portage (MI); Sur place; USD 89 000 - 149 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Formation

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

Outils

EMI/EMC testing equipment

Description du poste

Work Flexibility: Hybrid or Onsite

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.

Why Engineering at Stryker?

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!

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 Travel Percentage: 10%

Equal Opportunity Employment

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/F/Veteran/Disability. 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.

Work Flexibility Details

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.