Manager, Product Safety Engineering
$118k - $196.7kStryker
Work Flexibility: Hybrid or Onsite
Its Time to Join Stryker!
Why Join Us
At Stryker youll work on meaningful technology that directly impacts patient care. Youll 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 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
- Bachelors 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
- $118000 - $196700 USD Annual
Required Experience:
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