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. What You Will Do 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.
Preferred Qualifications
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 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. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.