Senior Software Requirements & Systems Engineer (Medical Devices) (Hybrid - Acton, MA or San Diego, CA)

Insulet Corporation•San Diego, MA

7h•Hybrid

About The Position

Lead the creation, analysis, and governance of software requirements for Insulet's next-gen wearable medical device, spanning mobile and cloud. This role owns end-to-end requirements quality and traceability in a regulated environment and partners closely with Systems, Software, V&V, Product, and Quality. Hands-on coding is not required.

Requirements

5+ years contributing to complex, safety-critical or regulated products (medical device preferred; aerospace/avionics, automotive, rail, or industrial safety acceptable).
Proven expertise writing and managing software and/or system requirements with strong decomposition, clarity, and testability.
Demonstrated knowledge of systems engineering practices: requirements management, risk analysis, and software/system architecture concepts.
Experience operating under a QMS/design controls and collaborating across Software, Systems, V&V, Quality, and Product.
Working knowledge of ALM tools (e.g., Polarion, Helix ALM, DOORS) and traceability methods.
Comfortable in Agile environments; able to align Definition of Ready/Done with regulatory needs.
Exceptional facilitation, documentation, and stakeholder communication skills.

Nice To Haves

Medical device standards: IEC 62304, ISO 14971, ISO 13485, 21 CFR 820.30 .
Formal training/certifications in Systems Engineering or Requirements Engineering (e.g., INCOSE, IREB/CPRE).
Familiarity with diabetes management products, mobile/cloud, IoT, cybersecurity/privacy (e.g., GDPR).
PLM change control experience.
Background with analogous safety standards ( DO-178C, ISO 26262, IEC 61508 ) with willingness to map to IEC 62304.

Responsibilities

Elicit, write, and refine clear, testable software requirements from user needs and product requirements.
Facilitate technical reviews with cross-functional stakeholders; drive alignment and decisions.
Build and maintain bidirectional traceability across user needs, hazards/risks, software requirements, design/architecture, and verification - per IEC 62304 and ISO 14971.
Generate trace reports for regulatory submissions and audits.
Administer and improve requirements in ALM/PLM (e.g., Polarion/Helix/DOORS + PLM), including versioning/baselining.
Review downstream artifacts (architecture/design, DFMEA/FMEA, test strategy/cases) to ensure implementation meets requirements.
Partner with Product Owners to translate requirements into Agile user stories with adequate acceptance criteria.
Contribute to continuous improvement of requirements practices, templates, and tool workflows.