Manager, Product Safety Engineering

Stryker • Portage, MI

7d • $118,000 - $196,700 • Hybrid

About The Position

Stryker is seeking a Manager, Product Safety to lead and evolve its product safety function supporting next-generation medical technologies. This role will drive global compliance strategies, oversee product safety engineering activities, and lead a high-performing team responsible for ensuring products meet the highest standards of safety, quality, and regulatory compliance. The position requires partnership with R&D, Quality, Regulatory, and cross-functional leaders to influence product design, support new product development, and ensure compliance across electrical, mechanical, and software systems. This is a high-impact leadership opportunity to shape product safety strategy while enabling innovation that improves patient outcomes.

Requirements

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related engineering discipline required
• 8+ years of relevant engineering experience in product safety, compliance, or related technical domain required
• 2+ years of leadership experience (direct people management or technical leadership) required

Nice To Haves

• Strong knowledge of FDA regulations, IEC standards, and global medical device compliance requirements
• Demonstrated ability to lead cross-functional initiatives and influence without authority
• Excellent communication, organizational, and analytical skills
• Experience leading product safety or compliance functions within the medical device industry
• Hands-on experience with electrical safety testing and certification processes (e.g., IEC 60601 series)
• Experience supporting global product development and commercialization efforts
• Track record of driving process improvements and operational efficiency initiatives

Responsibilities

• Lead, develop, and scale the Product Safety team, including resource planning to support new product development and sustaining initiatives
• Define and execute product safety strategies aligned with business objectives, regulatory requirements, and global standards
• Partner cross-functionally with R&D, Quality, Regulatory, and Operations to ensure product safety is embedded throughout the design control process
• Provide technical leadership on compliance to global standards (FDA, IEC, ISO) across electrical, mechanical, and software systems
• Oversee product safety testing, compliance activities, and lab operations including equipment, processes, and technology
• Lead audits and inspections with certification bodies and regulatory agencies, serving as the subject matter expert for product safety
• Drive continuous improvement initiatives, including process optimization, cost savings, and risk mitigation strategies
• Influence product design decisions to ensure compliance with global safety standards from concept through commercialization
• Build strong relationships with internal stakeholders and external partners (e.g., certification agencies, universities, industry groups)
• Establish and manage departmental budgets, ensuring alignment with organizational goals
• Identify and evaluate emerging technologies to support future product safety and business needs
• Assess and manage business risks related to product safety and regulatory compliance

Benefits

• 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.
• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager