Job Title: Senior Software Requirements & Systems Engineer
Duration: 6 months
Location: Hybrid (San Diego, CA)
 
Job description
Lead the creation, analysis, and governance of software requirements for company’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).

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.