Stryker

Manager, Product Safety Engineering

Stryker  •  $118k - $197k/yr  •  Michigan (Hybrid)  •  8 days ago
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Job Description

Work Flexibility: Hybrid or Onsite

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

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.

Stryker

About Stryker

Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.

Facts:

● 2024 Sales: $22.6 billion

● Industry: Medical Instruments & Supplies

● Employees: 53,000 worldwide

● 40 years of sales growth leading up to 2020

● 44+ Manufacturing and R&D Locations Worldwide

● $1.5 billion spent on research and development in 2024

● ~14,200 patents owned globally in 2024

● Products sold in ~75 countries

● Fortune 500 Company

● 7 consecutive years as one of Fortune's World's Best Workplaces

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Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Kalamazoo, MI
Year Founded
Unknown
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