Senior Compliance Engineer – Digital Health
Stryker
Senior Compliance Engineer – Digital Health
Job Description
Work Flexibility: HybridThe Senior Compliance Engineer will provide dedicated compliance engineering support for Stryker Medical’s growing Smart Care portfolio. Software as/in a Medical Device (SaMD + SiMD) will comprise the portfolio core along with supporting hardware, sensors, and customer applications. Partner with diverse teams to drive best in market digital health solutions supporting the caregiver, patient and families. Grow and adapt the technology & test roadmap to align with business ambition and future technology integration. Support digital and connected ecosystems through standards interpretation and test method mastery. Ensure state of the art interpretation of global compliance standards for medical and non-medical markets to enable globalization portfolio growth. This is a highly specialized individual contributor role that requires deep technical expertise and professional judgment. The Staff Compliance Engineer - Digital serves as a technical thought leader, providing guidance, influence, and direction across product development, certification strategy, and organizational best practices. Check out the products you’ll support here: Smart Care | StrykerThis role is hybrid expecting a minimum of 3 days a week in the Portage, MI office, typically Monday through Wednesday.What You Will DoLead product compliance strategy for new product development and sustaining engineering activities across the Smart Care portfolio.Translate global regulatory and compliance requirements into design inputs, verification plans, and market access strategies.Drive compliance activities throughout the product lifecycle, from concept development through verification, validation, and commercialization.Assess compliance risks, predicate product considerations, and emerging requirements to support informed design and business decisions.Partner with cross-functional teams to integrate compliance requirements into system architecture, product design, and technology roadmaps.Define compliance test strategies, methods, operating environments, and worst-case conditions to ensure robust product evaluations.Manage external testing laboratories, certification bodies, and third-party partners to support global certifications and regulatory submissions.Serve as a technical compliance subject matter expert, providing guidance during design reviews, risk assessments, and development activities.Influence organizational compliance practices by supporting procedure development, technical reviews, innovation opportunities, and cross-business initiatives.Collaborate with stakeholders, and business units to ensure compliance strategies align with user needs, product classifications, and market requirements.What You Need (Required Qualifications)Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline. 4+ years of compliance engineering experience required. Preferred QualificationsMaster’s degree in Computer Science, Software/Electrical Engineering or related discipline. Experience with product safety regulatory certification for major standards bodies and frameworks (IEC 60601-1, IEC 60601-1-8, FCC Requirements, IEC 62368-1 and others) Experience with medical device product development lifecycle, including design controls and risk management. Experience working with and managing third-party certification laboratories (e.g., UL, TÜV, CSA, Intertek). Experience with device regulatory certification involving safety, EMC, and/or wireless standards. Able to balance business and technical challenges to achieve financial outcomes. Knowledge of telecom/non-medical device standards. Familiarity with different software development life cycles. Basic knowledge of regulatory certification and device submission processes. Demonstrated ability to work independently and effectively in a matrixed organization. Demonstrated ability to effectively work cross-functionally with other departments, including Research & Development, Regulatory Affairs, and Marketing. Strong written, verbal, and interpersonal communication skills with the ability to influence without authority. $77,700 - $129,500 USD Annual Travel Percentage: 20%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.
Locations
- Michigan, Portage
- Michigan, Grand Rapids
Salary
77,700 - 129,500 USD / yearly
Skills Required
- medical device product development lifecycleintermediate
- device regulatory certification involving safetyintermediate
- telecom/non-medical device standardsintermediate
- different software development life cyclesintermediate
- regulatory certificationintermediate
Required Qualifications
- Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline. (degree in computer science)
- Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline. (degree in computer science)
- 4+ years of compliance engineering experience required. (experience, 4 years)
Preferred Qualifications
- Master’s degree in Computer Science, Software/Electrical Engineering or related discipline. (degree in computer science)
- Master’s degree in Computer Science, Software/Electrical Engineering or related discipline. (degree in computer science)
- Experience with product safety regulatory certification for major standards bodies and frameworks (IEC 60601-1, IEC 60601-1-8, FCC Requirements, IEC 62368-1 and others) (experience)
- Experience with product safety regulatory certification for major standards bodies and frameworks (IEC 60601-1, IEC 60601-1-8, FCC Requirements, IEC 62368-1 and others) (experience)
- Experience with medical device product development lifecycle, including design controls and risk management. (experience)
- Experience with medical device product development lifecycle, including design controls and risk management. (experience)
- Experience working with and managing third-party certification laboratories (e.g., UL, TÜV, CSA, Intertek). (experience)
- Experience working with and managing third-party certification laboratories (e.g., UL, TÜV, CSA, Intertek). (experience)
- Experience with device regulatory certification involving safety, EMC, and/or wireless standards. (experience)
- Experience with device regulatory certification involving safety, EMC, and/or wireless standards. (experience)
- Able to balance business and technical challenges to achieve financial outcomes. (experience)
- Able to balance business and technical challenges to achieve financial outcomes. (experience)
- Knowledge of telecom/non-medical device standards. (experience)
- Knowledge of telecom/non-medical device standards. (experience)
- Familiarity with different software development life cycles. (experience)
- Familiarity with different software development life cycles. (experience)
- Basic knowledge of regulatory certification and device submission processes. (certification)
- Basic knowledge of regulatory certification and device submission processes. (certification)
- Demonstrated ability to work independently and effectively in a matrixed organization. (experience)
- Demonstrated ability to work independently and effectively in a matrixed organization. (experience)
- Demonstrated ability to effectively work cross-functionally with other departments, including Research & Development, Regulatory Affairs, and Marketing. (experience)
- Demonstrated ability to effectively work cross-functionally with other departments, including Research & Development, Regulatory Affairs, and Marketing. (experience)
- Strong written, verbal, and interpersonal communication skills with the ability to influence without authority. (experience)
- Strong written, verbal, and interpersonal communication skills with the ability to influence without authority. (experience)
- $77,700 - $129,500 USD Annual (experience)
Responsibilities
- Lead product compliance strategy for new product development and sustaining engineering activities across the Smart Care portfolio.
- Translate global regulatory and compliance requirements into design inputs, verification plans, and market access strategies.
- Drive compliance activities throughout the product lifecycle, from concept development through verification, validation, and commercialization.
- Assess compliance risks, predicate product considerations, and emerging requirements to support informed design and business decisions.
- Partner with cross-functional teams to integrate compliance requirements into system architecture, product design, and technology roadmaps.
- Define compliance test strategies, methods, operating environments, and worst-case conditions to ensure robust product evaluations.
- Manage external testing laboratories, certification bodies, and third-party partners to support global certifications and regulatory submissions.
- Serve as a technical compliance subject matter expert, providing guidance during design reviews, risk assessments, and development activities.
- Influence organizational compliance practices by supporting procedure development, technical reviews, innovation opportunities, and cross-business initiatives.
- Collaborate with stakeholders, and business units to ensure compliance strategies align with user needs, product classifications, and market requirements.
- Lead product compliance strategy for new product development and sustaining engineering activities across the Smart Care portfolio.
- Translate global regulatory and compliance requirements into design inputs, verification plans, and market access strategies.
- Drive compliance activities throughout the product lifecycle, from concept development through verification, validation, and commercialization.
- Assess compliance risks, predicate product considerations, and emerging requirements to support informed design and business decisions.
- Partner with cross-functional teams to integrate compliance requirements into system architecture, product design, and technology roadmaps.
- Define compliance test strategies, methods, operating environments, and worst-case conditions to ensure robust product evaluations.
- Manage external testing laboratories, certification bodies, and third-party partners to support global certifications and regulatory submissions.
- Serve as a technical compliance subject matter expert, providing guidance during design reviews, risk assessments, and development activities.
- Influence organizational compliance practices by supporting procedure development, technical reviews, innovation opportunities, and cross-business initiatives.
- Collaborate with stakeholders, and business units to ensure compliance strategies align with user needs, product classifications, and market requirements.
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