Sr Systems Engineer, Risk Management (Hybrid - Acton, MA or San Diego, CA)

Insulet Corporation•Acton, MA

54d•Hybrid

About The Position

The Senior Systems Engineer - Risk Management ensures Insulet's medical device systems meet the highest standards of patient safety and regulatory compliance throughout the product lifecycle. This role focuses on system-level risk management for Insulet's connected drug delivery platforms, including the Omnipod ecosystem. The engineer will lead periodic reviews, PSUR updates, and impact assessments for post-market issues, ensuring field performance data continuously informs product safety and risk documentation. The engineer will also collaborate across software, hardware, usability, and quality teams to identify, evaluate, and control risks, ensuring risk management is seamlessly integrated into both design controls and post-market activities. This role is a part of the Research & Development Department (Systems COE).

Requirements

Bachelor's degree required (preferred field of study: Biomedical, Electrical, Mechanical, or related Engineering discipline).
6+ years of experience in a regulated medical device environment, ideally in connected drug delivery, wearable, or infusion systems.
Proven expertise in ISO 14971, ISO 13485, IEC 60601, IEC 62304, and IEC 62366.
Hands-on experience performing system-level hazard and risk analyses across both design and sustaining phases.
Strong understanding of post-market surveillance data interpretation, including complaint trending, PSUR updates, and CAPA risk assessment.
Ability to synthesize complex technical data and communicate risk-based decisions clearly across cross-functional teams.

Nice To Haves

Experience with connected medical systems, combination products, or drug delivery platforms.
Familiarity with risk and requirements management tools (e.g., Polarion).
Knowledge of cybersecurity and software risk management principles.
ASQ or ISO 14971-related certification preferred (e.g., CQE, CRE, Risk Management Professional).

Responsibilities

Lead system-level risk analyses throughout the product lifecycle, ensuring compliance with ISO 14971 and Insulet's Quality Management System.
Integrate risk management with design controls, maintaining traceability from hazards to requirements, verification, validation, and post-market surveillance.
Analyze post-market data (complaints, CAPAs, NCRs, field actions) to identify emerging risk trends and update risk documentation accordingly.
Support safety reporting by contributing to Periodic Safety Update Reports (PSURs) and Periodic Risk Reviews, summarizing field data and aligning with product safety assessments.
Drive cross-functional risk evaluations for escalations, health hazard assessments, and field corrective actions (FCAs), coordinating impact assessments and decision-making.
Maintain traceability between field performance data, CAPAs, and risk documentation (e.g., SHA, FMEA, Benefit-Risk Analysis).
Collaborate with the Global Product Monitoring (GPM) team to ensure consistent data interpretation and integration into product risk assessments.
Perform and maintain System Hazard Analyses (SHA), Fault Tree Analyses (FTA), and Failure Mode and Effects Analyses (FMEA) for complex electro-mechanical and software-enabled systems.
Collaborate with software, electrical, mechanical, and usability engineering teams to ensure design mitigations effectively address identified hazards.
Lead risk review boards and facilitate cross-functional risk assessments, driving consensus on safety classifications, acceptability, and corrective actions.
Evaluate and document benefit-risk assessments and overall residual risk for design changes, software updates, and new product introductions.
Harmonize and simplify risk management documentation, ensuring consistency across system and subsystem levels.
Provide guidance and training to project teams on risk management principles, processes, and regulatory expectations.
Prepare and present risk documentation during design reviews, internal audits, and regulatory inspections.