Senior Medical Device Compliance Engineer (Hybrid)

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

Job summary

Stryker is seeking a Senior Compliance Engineer to provide dedicated compliance engineering support for the Smart Care portfolio. The role focuses on SaMD/SiMD with supporting hardware, sensors, and customer applications, collaborating with cross-functional teams to globalize product compliance.

You will drive the design and verification strategy, ensure alignment with global standards, and guide risk assessments and design reviews to ensure market access and safe, compliant products.

Qualifications

• Bachelor's degree in Computer Science, Software/Electrical Engineering or related discipline.
• 2+ years of compliance engineering experience required.
• Master's degree in Computer Science, Software/Electrical Engineering or related discipline preferred.

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

2+ years compliance engineering

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

Job description

Stryker is seeking a Senior Compliance Engineer to provide dedicated compliance engineering support for the Smart Care portfolio. The role focuses on SaMD/SiMD with supporting hardware, sensors, and customer applications, collaborating with cross-functional teams to globalize product compliance.

You will drive the design and verification strategy, ensure alignment with global standards, and guide risk assessments and design reviews to ensure market access and safe, compliant products.