Manager, Product Safety Engineering

Posted 4 Days Ago
Be an Early Applicant
Portage, MI, USA
In-Office
118K-197K Annually
Senior level
Healthtech
The Role
Lead and evolve product safety function for medical technologies, ensuring compliance and safety standards, while managing a team and collaborating cross-functionally.
Summary Generated by Built In
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.

Skills Required

  • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related discipline
  • 8+ years of relevant engineering experience in product safety or compliance
  • 2+ years of leadership experience

Inari Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.

  • Fair & Transparent Compensation Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
  • Healthcare Strength Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
  • Leave & Time Off Breadth Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.

Inari Medical Insights

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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