Senior Compliance Engineer – Digital Health, Connected Medical Devices

Stryker

Senior compliance engineer guiding certification and regulatory strategy for Stryker’s connected medical-device Smart Care portfolio. Partnering across product development, testing, and commercialization.

Posted 8/10/2026full-timePortage • Missouri • 🇺🇸 United StatesSenior💰 $77,700 - $129,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in compliance engineering for medical devices, including regulatory certification processes and product safety standards. Proficient in managing compliance activities throughout the product development lifecycle while collaborating cross-functionally to align strategies with market requirements.

Highest-signal resume keywords

Compliance Engineering ExperienceRegulatory Certification KnowledgeProduct Safety Standards ExpertiseMedical Device Development LifecycleCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Compliance EngineeringRegulatory CertificationRisk ManagementDesign ControlsIEC 60601-1IEC 60601-1-8FCC RequirementsIEC 62368-1Device Submission ProcessesTelecom Standards

Soft Skills

Strong Communication SkillsInfluencing Without AuthorityIndependent WorkCross-Functional Teamwork

Tools & Technologies

Third-Party Certification LaboratoriesULTÜVCSAIntertek

Industry Keywords

Medical DeviceCompliance StrategyProduct DevelopmentVerification PlansMarket Access Strategies

About the role

Key responsibilities & impact

Provide dedicated compliance engineering support for Stryker Medical’s Smart Care portfolio of software as/in a Medical Device, hardware, sensors, and customer applications
Lead product compliance strategy for new product development and sustaining engineering activities
Translate global regulatory and compliance requirements into design inputs, verification plans, and market access strategies
Drive compliance activities from concept development through verification, validation, and commercialization
Assess compliance risks, predicate product considerations, and emerging requirements
Integrate compliance requirements into system architecture, product design, and technology roadmaps
Define compliance test strategies, methods, operating environments, and worst-case conditions
Manage external testing laboratories, certification bodies, and third-party partners for global certifications and regulatory submissions
Serve as a technical compliance subject matter expert during design reviews, risk assessments, and development activities
Support procedure development, technical reviews, innovation opportunities, and cross-business initiatives
Collaborate with stakeholders and business units to align compliance strategies with user needs, product classifications, and market requirements

Requirements

What you’ll need

Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline
4+ years of compliance engineering experience required
Experience with product safety regulatory certification for major standards bodies and frameworks, including IEC 60601-1, IEC 60601-1-8, FCC Requirements, and IEC 62368-1
Experience with medical device product development lifecycle, including design controls and risk management
Experience working with and managing third-party certification laboratories such as UL, TÜV, CSA, and Intertek
Experience with device regulatory certification involving safety, EMC, and/or wireless standards
Knowledge of telecom/non-medical device standards
Familiarity with different software development life cycles
Basic knowledge of regulatory certification and device submission processes
Ability to work independently and effectively in a matrixed organization
Ability to work cross-functionally with Research & Development, Regulatory Affairs, and Marketing
Strong written, verbal, and interpersonal communication skills with the ability to influence without authority

Benefits

Comp & perks

Hybrid work arrangement
Annual salary of $77,700–$129,500 USD
20% travel opportunity/requirement