Principal Product Safety Engineer

Work Flexibility: Hybrid or Onsite

As Principal Product Safety Engineer, you will lead safety initiatives for new and existing products for our Instruments Neurosurgical 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.

This role is hybrid in Portage, MI with the expectation to be in office 3-4 days a week.

Check out our product portfolio: Stryker Neurosurgical

What you will do:

• 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.
• Apply and mentor others on advanced engineering theories, principles, and concepts across various products to comply with Product safety compliance standards within business unit and team.
• 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

What you need:

Required Qualifications:

• Bachelor's degree in Electrical Engineering or Biomedical Engineering or related discipline
• 8+ years of overall work experience
• 5+ years of work experience in the field of electrical engineering or equivalent in a regulated industry.
• Possess an understanding of IEC standards and an understanding of compliance or related regulatory compliance standards.

Preferred Qualifications:

• Working knowledge of regulations and standards related to Medical (60601) products
• Experience in supporting internal and external audits.
• Knowledge of basic electrical circuits and basic EMC testing concepts
• Medical devices safety testing experience; working knowledge of IEC 60601 family of standards is desired
• Experience with accepted industry standards for product safety testing 

Travel Percentage: 10%

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.