Sr. SW DQA Engineer - Embedded SW (Hybrid - Acton, MA)
Insulet Corporation · Acton, Massachusetts, US
Position Overview: The Senior Design Assurance Engineer is responsible for ensuring that Insulet’s medical device product meet quality, safety and regulatory...
Job description
Position Overview: The Senior Design Assurance Engineer is responsible for ensuring that Insulet’s medical device product meet quality, safety and regulatory requirements throughout the development lifecycle. This role focuses on embedded software systems and ensures compliance with applicable standards, regulations and guidance documents for medical devices containing Embedded Software. This role interfaces with other Insulet departments (e.g. Systems Engineering, Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and services to support our medical devices, partner integrations, and data analytics. Serve as a key DQA contributor within cross‑functional development teams, supporting end‑to‑end development of Embedded Software Systems and associated system components. Provide expert guidance on the development, review, and maintenance of requirements, specifications, design documentation, verification plans, test protocols, test reports, traceability matrices, and other essential technical documentation. Knowledge of com...