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

Overview
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.

 

What you'll do

• • 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.

What you'll bring (Required)

• • 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 have

• • 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.

Education

• • Bachelor’s degree in systems, Biomedical, Electrical, Computer Engineering/Science or related field (or equivalent experience).
     

This position focuses on requirements engineering and compliance for software in a medical device context; coding is not required. Candidates from other regulated industries with strong requirements/traceability experience are encouraged to apply.

 

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).

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