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

What You Will Need

• 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)

Preferred Qualifications

• 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

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 and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and 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.

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.