Manager, Product Safety Engineering
It’s Time to Join Stryker!
Why Join Us?At Stryker, you’ll work on meaningful technology that directly impacts patient care. You’ll be part of a collaborative, mission-driven team where innovation, quality, and continuous improvement are at the center of everything we do.
We are seeking a Manager, Product Safety to lead and evolve our product safety function supporting next-generation medical technologies. In this role, you will drive global compliance strategies, oversee product safety engineering activities, and lead a high-performing team responsible for ensuring our products meet the highest standards of safety, quality, and regulatory compliance.
You will partner closely 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.
What You Will Do- 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
- 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)
- 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
- $118,000 - $196,700 USD Annual
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