SPECTRAFORCE
Senior Software Requirements & Systems Engineer
SPECTRAFORCE, San Diego, California, United States, 92189
Senior Software Requirements & Systems Engineer
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
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).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr
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
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).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr