Senior Compliance Engineer – Digital Health, Connected Medical Devices

Responsibilities

• 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

• 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

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.

• Compliance Engineering Experience
• Regulatory Certification Knowledge
• Product Safety Standards Expertise
• Medical Device Development Lifecycle
• Cross-Functional Collaboration

• Compliance Engineering
• Regulatory Certification
• Risk Management
• Design Controls
• IEC 60601-1
• IEC 60601-1-8
• FCC Requirements
• IEC 62368-1
• Device Submission Processes
• Telecom Standards

• Strong Communication Skills
• Influencing Without Authority
• Independent Work
• Cross-Functional Teamwork

• Medical Device
• Compliance Strategy
• Product Development
• Verification Plans
• Market Access Strategies

• Third-Party Certification Laboratories
• UL
• TÜV
• CSA
• Intertek