Senior Compliance Engineer – Digital Health SaMD

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Wellbeing program

Tobacco cessation program

Job summary

Stryker in Portage, MI is seeking a Senior Compliance Engineer to provide dedicated compliance engineering support for the Smart Care portfolio, focusing on SaMD and SiMD with supporting hardware and sensors. You will translate regulatory requirements into design inputs and test plans across the product lifecycle.

This role is a technical contributor and thought leader, guiding certification strategy, risk management, and cross-functional collaboration with R&D, Regulatory Affairs, and Marketing

Qualifications

• Bachelor’s degree in Computer Science, Software or Electrical Engineering or related discipline.
• 4+ years of compliance engineering experience.

Responsibilities

• Lead product compliance strategy across the Smart Care portfolio.
• Translate global regulatory requirements into design inputs, verification plans, and market access strategies.
• Drive compliance activities throughout the product lifecycle from concept to commercialization.
• Assess compliance risks and emerging requirements to inform design and decisions.
• Partner with cross-functional teams to integrate compliance into system architecture and roadmaps.
• Define compliance test strategies, environments, and worst-case conditions for robust evaluations.

Skills

Regulatory compliance

Cross-functional collaboration

Risk management

Design reviews

Education

Bachelor’s degree in CS/EE or related

Master’s degree in CS/EE or related

Tools

Certification labs management

Job description

Stryker in Portage, MI is seeking a Senior Compliance Engineer to provide dedicated compliance engineering support for the Smart Care portfolio, focusing on SaMD and SiMD with supporting hardware and sensors. You will translate regulatory requirements into design inputs and test plans across the product lifecycle.

This role is a technical contributor and thought leader, guiding certification strategy, risk management, and cross-functional collaboration with R&D, Regulatory Affairs, and Marketing