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
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 contractors legal duty to furnish information.
Required Experience:
Manager
Work Flexibility: Hybrid or OnsiteIts Time to Join Stryker!Why Join UsAt 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 a...
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
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 contractors legal duty to furnish information.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid
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