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

• 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., 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 Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

• 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., + 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).

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