Lead the creation, analysis, and governance of software requirements for Insulet's next-gen wearable medical device, spanning mobile and cloud, in a regulated environment.
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.
- Medical device standards: IEC 62304, ISO 14971, ISO 13485, 21 CFR 820.30.
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.
Other
- Exceptional facilitation, documentation, and stakeholder communication skills.
- 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.
