Senior Software Requirements & Systems Engineer

Job Description:
Job Title: Senior Software Requirements & Systems Engineer
Location: Hybrid in San Diego, CA 92121
Duration : 06+ Months (Possible extension or conversion)
Pay Rate: $80.00 to $84.00/hr. ON W2
Overview:
Lead the creation, analysis, and governance of software requirements for ***'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.
Responsibilities:
o Elicit, write, and refine clear, testable software requirements from user needs and product requirements.
o Facilitate technical reviews with cross-functional stakeholders; drive alignment and decisions.
o Build and maintain bidirectional traceability across user needs, hazards/risks, software requirements, design/architecture, and verification - per IEC 62304 and ISO 14971.
o Generate trace reports for regulatory submissions and audits.
o Administer and improve requirements in ALM/PLM (e.g., Polarion/Helix/DOORS + PLM), including versioning/baselining.
o Review downstream artifacts (architecture/design, DFMEA/FMEA, test strategy/cases) to ensure implementation meets requirements.
o Partner with Product Owners to translate requirements into Agile user stories with adequate acceptance criteria.
o Contribute to continuous improvement of requirements practices, templates, and tool workflows.
What you'll bring (Required)
o 5+ years contributing to complex, safety-critical or regulated products (medical device preferred; aerospace/avionics, automotive, rail, or industrial safety acceptable).
o Proven expertise writing and managing software and/or system requirements with strong decomposition, clarity, and testability.
o Demonstrated knowledge of systems engineering practices: requirements management, risk analysis, and software/system architecture concepts.
o Experience operating under a QMS/design controls and collaborating across Software, Systems, V&V, Quality, and Product.
o Working knowledge of ALM tools (e.g., Polarion, Helix ALM, DOORS) and traceability methods.
o Comfortable in Agile environments; able to align Definition of Ready/Done with regulatory needs.
o Exceptional facilitation, documentation, and stakeholder communication skills.
Nice to have
o Medical device standards: IEC 62304, ISO 14971, ISO 13485, 21 CFR 820.30.
o Formal training/certifications in Systems Engineering or Requirements Engineering (e.g., INCOSE, IREB/CPRE).
o Familiarity with diabetes management products, mobile/cloud, IoT, cybersecurity/privacy (e.g., GDPR).
o PLM change control experience.
o Background with analogous safety standards (DO-178C, ISO 26262, IEC 61508) with willingness to map to IEC 62304.
Education
o 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.
Start Date - End Date:
Nov 10, 2025 - May 8, 2026