Position Overview

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.

Responsibilities Include:

·       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.

·       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.

Minimum 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.

Preferred Qualifications:

·       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.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid

Additional Information:



Compensation & Benefits:

For U.S.-based positions only, the annual base salary range for this role is $102,400.00 - $153,550.00

This position may also be eligible for incentive compensation.

We offer a comprehensive benefits package, including:
• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs

Application Details:
This job posting will remain open until the position is filled.
To apply, please visit the Insulet Careers site and submit your application online.

Actual pay depends on skills, experience, and education.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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