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Senior Compliance Engineer

Stryker
Portage, USA
Full-time
Senior · 2+ years experience
Onsite
USD 77700-129500 / year
Discovered Today
Communication

Full Job Posting

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.
  • 2+ 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

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