Diabetes Youth Families

Senior Compliance Engineer

Diabetes Youth Families

full-time

Posted on:

Location Type: Hybrid

Location: Acton • Massachusetts • United States

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Salary

💰 $102,400 - $153,550 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
compliance engineeringsystems engineeringrequirements managementhazard analysissafety assessmentsrisk managementmedical device standardsISO 13485IEC 6230421 CFR 820.30
Soft Skills
collaborationcommunicationleadershiporganizational skillscross-functional teamworkguidanceaudit readinessproblem-solvingstakeholder managementadaptability
Certifications
Bachelor's degreeMaster's degreeISO 13485 certificationIEC 62304 certification21 CFR 820.30 certificationEU MDR certificationmedical device compliance certificationssystems engineering certificationrisk management certificationquality assurance certification