Senior Compliance Engineer

Role Overview

• Serve as a key member of cross‑functional project teams, including electrical, software, mechanical, manufacturing, and quality engineering, to support design, development, launch readiness, and lifecycle maintenance.
• Interface with nationally recognized test laboratories (NRTLs) to obtain and maintain product certifications.
• Collaborate with R&D staff to ensure consistent understanding and application of relevant standards and regulatory requirements across engineering disciplines.
• Develop compliance plans tailored to the scope, risk, and intended use of each program.
• Determine applicable U.S. and international standards in collaboration with Systems Engineering Leads, Regulatory Affairs, and Quality.
• Maintain working knowledge of FDA guidance and global standards related to mobile device technologies in medical products.
• Interpret external standards and ensure ongoing compliance via reviews of product changes.
• Monitor changes to regulatory requirements and external standards, performing gap analyses and communicating impacts to internal stakeholders.
• Coordinate and support system-level testing against relevant external safety, software, EMC, usability, and wireless standards.
• Organize and manage third‑party lab testing, documentation, reports, and compliance activities.
• Ensure that components critical to product safety are certified and properly documented.
• Audit Support & Compliance Governance
• Support internal audit readiness activities and respond to certification body inquiries.
• Coordinate cross‑functional compliance activities, ensuring alignment with program timelines, deliverables, and quality system requirements.
• Provide guidance to senior and executive leadership on critical compliance matters impacting product development, certification, or market access.

Requirements

• Bachelor’s degree required (preferred field of study: Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, Biomedical Engineering, or related technical field); Master’s degree preferred.
• Minimum five (5) years of experience as a Systems or Compliance Engineer in a multidisciplinary medical device environment.
• Five (5)+ years leading compliance‑specific initiatives for regulated medical devices in U.S. and international markets.
• Proficiency with key medical device standards and regulations, including ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, 21 CFR 820.30, and EU MDR; knowledge of additional in‑country standards is a plus.
• Domain expertise in one or more engineering disciplines, preferably Electrical Engineering, with exposure to Mechanical, Quality, and Test Engineering.
• Demonstrated systems engineering skills including requirements management, design trade‑offs, hazard analysis, safety assessments, and risk management.
• Deep understanding of medical device and software compliance standards, and the ability to apply appropriate test strategies based on device design.
• Proven ability to work effectively under a Quality Management System (QMS) within cross‑functional teams across development, V&V, manufacturing, regulatory, marketing, clinical, and quality functions.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs