Senior Compliance Engineer

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.

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.
• 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.