Senior Software Requirements and Systems Engineer (San Diego)

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

Preferred Qualifications

Education