Senior Compliance Engineer (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

3d•$102,400 - $153,550•Hybrid

About The Position

The Sr. Compliance Engineer is a technical leader within the R&D Systems Engineering Center of Excellence. This role supports the design, development, and lifecycle of Insulet’s products, ensuring compliance with global regulatory requirements and international standards for medical devices incorporating mobile and connected technologies. The position partners closely with Regulatory Affairs, cross‑functional R&D project and program teams, and third‑party test laboratories to plan, generate, and maintain evidence needed for product certification and regulatory submissions. The Sr. Compliance Engineer leads and prioritizes compliance activities across multiple programs and workstreams to ensure Insulet’s insulin delivery systems remain safe, effective, and in full conformity with applicable standards throughout their lifecycle. Success in this role requires broad engineering experience across mobile and wearable app software, embedded hardware, electromechanical systems, wireless communication technologies, and system-level safety practices.

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.

Nice To Haves

Demonstrated ability to manage multiple tasks and set priorities effectively in a fast‑changing environment.
Extensive knowledge of diabetes technology and insulin delivery systems.
Experience or formal training in systems engineering methodologies and mobile application technologies.
Experience bringing innovative FDA‑regulated medical devices to market, especially in drug delivery or connected therapeutics.

Responsibilities

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.
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.
Organize compliance schedules, cost estimates, and resource needs to support program and portfolio activities.
Lead and prioritize compliance work across multiple projects, balancing short‑term execution with long‑term lifecycle support.