Advantage Technical
Senior Software Requirements and Systems Engineer
Advantage Technical, San Diego, California, United States, 92189
Senior Software Requirements Engineer – Medical Devices
Location:
Hybrid (Must be commutable to San Diego, CA office)
Position Overview We are seeking a Software Requirements Engineer to lead the creation, analysis, and governance of software requirements for our client's next-generation wearable medical device, spanning mobile and cloud platforms. This role is responsible for ensuring end-to-end requirements quality and traceability in a regulated environment, working closely with cross-functional teams including Systems Engineering, Software Development, Verification & Validation, Product Management, and Quality Assurance. This is a non-coding role focused on requirements engineering and compliance.
Responsibilities
Elicit, write, and refine clear, testable software requirements based on user needs and product specifications
Facilitate technical reviews with cross-functional stakeholders to drive alignment and decision-making
Establish and maintain bidirectional traceability across user needs, hazards/risks, software requirements, design/architecture, and verification activities in accordance with IEC 62304 and ISO 14971
Generate traceability reports for regulatory submissions and audits
Administer and enhance requirements within ALM/PLM tools (e.g., Polarion, Helix, DOORS, PLM), including version control and baselining
Review downstream artifacts such as architecture, design, DFMEA/FMEA, and test strategies to ensure alignment with requirements
Collaborate with Product Owners to translate requirements into Agile user stories with appropriate acceptance criteria
Contribute to the continuous improvement of requirements practices, templates, and tool workflows
Required Qualifications
Minimum 5 years of experience working on complex, safety-critical, or regulated products (medical device preferred; aerospace, automotive, rail, or industrial safety acceptable)
Proven ability to write and manage software/system requirements with strong decomposition, clarity, and testability
Solid understanding of systems engineering principles including requirements management, risk analysis, and architecture
Experience working within a quality management system and design controls
Proficiency with ALM tools such as Polarion, Helix ALM, or DOORS
Familiarity with Agile development environments and regulatory alignment of Definition of Ready/Done
Strong facilitation, documentation, and communication skills
Preferred Qualifications
Knowledge of medical device standards including IEC 62304, ISO 14971, ISO 13485, and 21 CFR 820.30
Certifications in Systems or Requirements Engineering (e.g., INCOSE, IREB/CPRE)
Experience with diabetes management technologies, mobile/cloud platforms, IoT, and cybersecurity/privacy regulations (e.g., GDPR)
PLM change control experienceBackground in analogous safety standards such as DO-178C, ISO 26262, or IEC 61508 with the ability to map to IEC 62304
Education
Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Engineering/Science, or a related field (or equivalent experience)
Seniority level Mid-Senior level
Employment type Contract
Job function Medical Equipment Manufacturing
#J-18808-Ljbffr
Hybrid (Must be commutable to San Diego, CA office)
Position Overview We are seeking a Software Requirements Engineer to lead the creation, analysis, and governance of software requirements for our client's next-generation wearable medical device, spanning mobile and cloud platforms. This role is responsible for ensuring end-to-end requirements quality and traceability in a regulated environment, working closely with cross-functional teams including Systems Engineering, Software Development, Verification & Validation, Product Management, and Quality Assurance. This is a non-coding role focused on requirements engineering and compliance.
Responsibilities
Elicit, write, and refine clear, testable software requirements based on user needs and product specifications
Facilitate technical reviews with cross-functional stakeholders to drive alignment and decision-making
Establish and maintain bidirectional traceability across user needs, hazards/risks, software requirements, design/architecture, and verification activities in accordance with IEC 62304 and ISO 14971
Generate traceability reports for regulatory submissions and audits
Administer and enhance requirements within ALM/PLM tools (e.g., Polarion, Helix, DOORS, PLM), including version control and baselining
Review downstream artifacts such as architecture, design, DFMEA/FMEA, and test strategies to ensure alignment with requirements
Collaborate with Product Owners to translate requirements into Agile user stories with appropriate acceptance criteria
Contribute to the continuous improvement of requirements practices, templates, and tool workflows
Required Qualifications
Minimum 5 years of experience working on complex, safety-critical, or regulated products (medical device preferred; aerospace, automotive, rail, or industrial safety acceptable)
Proven ability to write and manage software/system requirements with strong decomposition, clarity, and testability
Solid understanding of systems engineering principles including requirements management, risk analysis, and architecture
Experience working within a quality management system and design controls
Proficiency with ALM tools such as Polarion, Helix ALM, or DOORS
Familiarity with Agile development environments and regulatory alignment of Definition of Ready/Done
Strong facilitation, documentation, and communication skills
Preferred Qualifications
Knowledge of medical device standards including IEC 62304, ISO 14971, ISO 13485, and 21 CFR 820.30
Certifications in Systems or Requirements Engineering (e.g., INCOSE, IREB/CPRE)
Experience with diabetes management technologies, mobile/cloud platforms, IoT, and cybersecurity/privacy regulations (e.g., GDPR)
PLM change control experienceBackground in analogous safety standards such as DO-178C, ISO 26262, or IEC 61508 with the ability to map to IEC 62304
Education
Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Engineering/Science, or a related field (or equivalent experience)
Seniority level Mid-Senior level
Employment type Contract
Job function Medical Equipment Manufacturing
#J-18808-Ljbffr