Senior Compliance Engineer

What You'll Work On

• Serves as a technical lead and subject matter expert for product compliance activities across new product development and sustaining engineering projects
• Evaluates product designs against applicable national and international standards, including electrical safety, electromagnetic compatibility (EMC), wireless, environmental, and medical device-specific requirements
• Develops compliance strategies, test plans, protocols, and reports to support product verification, validation, regulatory submissions, and market access activities
• Collaborates closely with systems, electrical, firmware, mechanical, quality, regulatory, and manufacturing teams to ensure compliance requirements are incorporated throughout the design and development process
• Partners with external test laboratories, certification bodies, and regulatory organizations to plan, execute, and successfully complete compliance testing and product certifications
• Conducts impact assessments for product changes, component substitutions, manufacturing changes, and design modifications to determine compliance implications and required testing
• Monitors revisions to applicable standards and regulations, evaluates their impact on existing and future products, and develops implementation plans to maintain compliance
• Investigates compliance-related issues, supports root cause analysis activities, and develops corrective actions to address identified gaps or nonconformances
• Effectively communicates compliance requirements, risks, testing results, and recommendations across all levels of the organization to support informed decision-making and successful product development

Minimum Qualifications

• Bachelor's degree in Electrical Engineering or related engineering discipline
• Minimum 5 years of experience in product compliance, electrical engineering, or a related field
• Experience interpreting and applying technical standards and regulatory requirements to electronic products
• Experience developing and executing compliance testing programs, including test plans, protocols, and reports
• Experience working with external test laboratories and certification organizations
• Experience performing engineering assessments, risk evaluations, and impact analyses for product or process changes
• Experience working in a regulated product development environment
• Strong analytical, problem-solving, technical writing, and communication skills

Preferred Qualifications

• 7+ years of experience supporting compliance activities for complex electronic or medical device products
• Experience with Class II or Class III medical devices
• Strong knowledge of medical device standards, including IEC 60601 series, ISO 14708 series, IEC 62304, ISO 10993, IEC 60601-1-2, FCC, RED, and other applicable regulatory requirements
• Experience supporting implantable, externally worn, or wireless medical device systems
• Experience conducting EMC, electrical safety, environmental, reliability, and wireless compliance evaluations
• Experience assessing the impact of standards revisions and regulatory changes on existing product portfolios
• Experience working with cross-functional product development teams throughout the product lifecycle