Sr. SW DQA Engineer - Embedded SW (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

3d•Hybrid

About The Position

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 complex embedded systems, control systems theory, algorithms, real-time operating systems (RTOS), and signal processing. Ensure adherence to Design Controls processes by providing oversight and guidance for the creation, review, and approval of all Design History File (DHF) deliverables. Review, evaluate, and approve design control documentation (e.g., plans, protocols, reports) to ensure alignment with the Insulet Quality System, Quality System Regulation, and ISO 13485 requirements. Ensures compliance and execution to Software Development Life Cycle (IEC 62304) and risk management activities (ISO 14971), including FMEAs. Support cybersecurity risk‑management activities. Contribute to quality‑focused process and product improvement initiatives across the Development Lifecycle, ensuring DQA practices align with industry best practices. Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking, configuration management and design transfer activities. Apply structured, data-driven problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues. Advise teams to ensure compliance with country‑specific regulations and requirements for targeted distribution markets. Support manufacturing process development and qualification activities for new product launches and product changes. Other duties as assigned.

Requirements

BS degree, in Computer Science, Software Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or equivalent science degree.
5-7 years work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience.
Experience with Design Controls (FDA 21 CFR Part 820), and Design and Development /Product Realization (ISO 13485).
Experience with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, and cybersecurity).
Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.

Nice To Haves

Effective verbal and written communication skills.
Master’s degree preferred.
ASQ, CQE or other quality certificates are preferred.
Demonstrated ability to collaborate with individuals at multiple levels across the organization.
Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
Strong analytical and problem-solving skills.
Able to work effectively in a high-stress, high-energy environment.
Ability to follow up with task owners on projects in a fast-moving environment.

Responsibilities

Ensuring that Insulet’s medical device product meet quality, safety and regulatory requirements throughout the development lifecycle.
Focuses on embedded software systems and ensures compliance with applicable standards, regulations and guidance documents for medical devices containing Embedded Software.
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.
Ensure adherence to Design Controls processes by providing oversight and guidance for the creation, review, and approval of all Design History File (DHF) deliverables.
Review, evaluate, and approve design control documentation (e.g., plans, protocols, reports) to ensure alignment with the Insulet Quality System, Quality System Regulation, and ISO 13485 requirements.
Ensures compliance and execution to Software Development Life Cycle (IEC 62304) and risk management activities (ISO 14971), including FMEAs.
Support cybersecurity risk‑management activities.
Contribute to quality‑focused process and product improvement initiatives across the Development Lifecycle, ensuring DQA practices align with industry best practices.
Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking, configuration management and design transfer activities.
Apply structured, data-driven problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Advise teams to ensure compliance with country‑specific regulations and requirements for targeted distribution markets.
Support manufacturing process development and qualification activities for new product launches and product changes.
Other duties as assigned.