Senior Software Requirements and Systems Engineer Job at Advantage Technical in

Job Title: 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 experience
• Background 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)