Senior Compliance Engineer, Digital Health (Hybrid)

PowerToFly; Grand Rapids (MI); Hybrid; USD 78,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Health Savings Account (HSA)

Job summary

Stryker is seeking a Senior Compliance Engineer to provide expert compliance support for the Smart Care SaMD/SiMD portfolio. You will translate global standards into design inputs, guide verification and validation, and drive regulatory submissions across the product lifecycle while collaborating with R&D, Regulatory Affairs, and Marketing.

Hybrid role with in-office cadence in Portage, MI. You will lead testing strategies, manage labs and partner with external bodies to enable globalization of

Qualifications

• Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline.
• 4+ years of compliance engineering experience.
• Master’s degree in Computer Science, Software/Electrical Engineering or related discipline (preferred).
• 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 R&D, Regulatory Affairs, and Marketing.
• Strong written, verbal, and interpersonal communication skills with the ability to influence without authority.

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.

Skills

Compliance engineering

Regulatory requirements

Cross-functional collaboration

Technical leadership

Communication skills

Education

Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline

Master’s degree in Computer Science, Software/Electrical Engineering or related discipline

Tools

UL

TÜV

CSA

Intertek

Job description

Stryker is seeking a Senior Compliance Engineer to provide expert compliance support for the Smart Care SaMD/SiMD portfolio. You will translate global standards into design inputs, guide verification and validation, and drive regulatory submissions across the product lifecycle while collaborating with R&D, Regulatory Affairs, and Marketing.

Hybrid role with in-office cadence in Portage, MI. You will lead testing strategies, manage labs and partner with external bodies to enable globalization of