Senior Compliance Engineer – Digital Health

Work Flexibility: Hybrid The 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 | Stryker This role is hybrid expecting a minimum of 3 days a week in the Portage, MI office, typically Monday through Wednesday.

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. What You Need (Required Qualifications) Bachelor’s degree in Computer Science , Software/ Electrical Engineering or related discipline.   4 + years of compliance engineering experience required .

Master’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