Stryker Corporation

Senior Compliance Engineer - Digital Health

Stryker Corporation • $77K — $129K *
Grand Rapids, MI 49504In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Computer Science, Software/Electrical Engineering or related field.
  • 4+ years of compliance engineering experience required.
  • Master's degree in a relevant field preferred.
  • Experience with product safety regulatory certification for standards (like IEC 60601-1).
  • Experience with medical device product development lifecycle, including design controls and risk management.
  • Knowledge of telecom/non-medical device standards.

Responsibilities

  • Lead product compliance strategy for new product development and sustaining engineering activities.
  • Translate global regulatory requirements into design inputs and market access strategies.
  • Drive compliance activities throughout the product lifecycle from concept to commercialization.
  • Assess compliance risks and emerging requirements to support design decisions.
  • Partner with cross-functional teams to integrate compliance into product design.
  • Manage external testing laboratories and certification bodies for global submissions.
  • Influence compliance practices by supporting procedure development and innovation.

Benefits

  • Work flexibility with a hybrid environment.
  • Opportunity to contribute to innovative health technology projects.
  • Collaboration with diverse teams across the organization.
  • Involvement in global compliance strategies and market access.
Full Job Description
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%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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