Overview Lead the creation, analysis, and governance of software requirements for Insulets 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&amp;V, Product, and Quality. Hands-on coding is not required.What youll do<ul><li>Elicit, write, and refine clear, testable software requirements from user needs and product requirements.</li><li>Facilitate technical reviews with cross-functional stakeholders; drive alignment and decisions.</li><li>Build and maintain bidirectional traceability across user needs, hazards/risks, software requirements, design/architecture, and verification - per IEC 62304 and ISO 14971.</li><li>Generate trace reports for regulatory submissions and audits.</li><li>Administer and improve requirements in ALM/PLM (e.g., Polarion/Helix/DOORS + PLM), including versioning/baselining.</li><li>Review downstream artifacts (architecture/design, DFMEA/FMEA, test strategy/cases) to ensure implementation meets requirements.</li><li>Partner with Product Owners to translate requirements into Agile user stories with adequate acceptance criteria.</li><li>Contribute to continuous improvement of requirements practices, templates, and tool workflows.</li></ul>What youll bring (Required)<ul><li>5+ years contributing to complex, safety-critical or regulated products (medical device preferred; aerospace/avionics, automotive, rail, or industrial safety acceptable).</li><li>Proven expertise writing and managing software and/or system requirements with strong decomposition, clarity, and testability.</li><li>Demonstrated knowledge of systems engineering practices: requirements management, risk analysis, and software/system architecture concepts.</li><li>Experience operating under a QMS/design controls and collaborating across Software, Systems, V&amp;V, Quality, and Product.</li><li>Working knowledge of ALM tools (e.g., Polarion, Helix ALM, DOORS) and traceability methods.</li><li>Comfortable in Agile environments; able to align Definition of Ready/Done with regulatory needs.</li><li>Exceptional facilitation, documentation, and stakeholder communication skills.</li></ul>Nice to have<ul><li>Medical device standards: IEC 62304, ISO 14971, ISO 13485, 21 CFR 820.30.</li><li>Formal training/certifications in Systems Engineering or Requirements Engineering (e.g., INCOSE, IREB/CPRE).</li><li>Familiarity with diabetes management products, mobile/cloud, IoT, cybersecurity/privacy (e.g., GDPR).</li><li>PLM change control experience.</li><li>Background with analogous safety standards (DO-178C, ISO 26262, IEC 61508) with willingness to map to IEC 62304.</li></ul>Education<ul><li>Bachelor’s degree in systems, Biomedical, Electrical, Computer Engineering/Science or related field (or equivalent experience).  </li></ul>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). #LI-Hybrid Additional Information:The US base salary range for this full-time position is $109,800.00 - $164,700.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.<div>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!At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.<div><div><div><div><div><div><div>(<a href="https://www.eeoc.gov/poster" target="_blank">Know Your Rights</a>)</div></div></div></div></div></div></div></div>

Insulet

Senior Software Requirements & Systems Engineer (Medical Devices) (Hybrid)

Insulet

Similar Remote Jobs