Job Title : Software Requirements Engineer – Medical Device (Hybrid, San Diego, CA)
Overview
Join a dynamic team leading the next generation of wearable medical technology. This role is responsible for driving software requirements engineering and compliance across mobile and cloud platforms in a regulated environment. You'll ensure end-to-end requirements quality, traceability, and alignment with industry standards—without the need for hands-on coding.
Key Responsibilities
- Elicit, write, and refine clear, testable software requirements from user and product needs.
- Facilitate technical reviews with cross-functional stakeholders and drive decisions.
- Build and maintain full traceability across user needs, hazards / risks, requirements, design, and verification.
- Generate trace reports to support audits and regulatory submissions.
- Administer and improve ALM / PLM tools (e.g., Polarion, Helix, DOORS) including baselining and versioning.
- Partner with Product Owners to translate requirements into Agile user stories.
- Contribute to continuous improvement of requirements engineering practices and templates.
What You Bring
5+ years working on complex, regulated, or safety-critical products (medical device preferred; aerospace, automotive, or other regulated industries welcome).Proven expertise in writing and managing software / system requirements with strong clarity, decomposition, and testability.Knowledge of systems engineering, risk analysis, and architecture concepts.Experience collaborating within a QMS / design controls framework.Strong familiarity with ALM tools and traceability methods.Excellent facilitation, documentation, and stakeholder communication skills.Preferred
Knowledge of IEC 62304, ISO 14971, ISO 13485, or similar safety standards.Systems / Requirements Engineering certifications (INCOSE, IREB / CPRE).Background in diabetes management, mobile / cloud, IoT, or cybersecurity.Education
Bachelor's degree in Systems, Biomedical, Electrical, Computer Engineering / Science or related field, or equivalent experience.Why Apply?
This is an opportunity to shape the requirements foundation of life-changing medical technology while working in a collaborative, hybrid environment. If you're passionate about requirements engineering and compliance in safety-critical domains, we want to hear from you.
?? Apply today and be a key player in developing innovative solutions that improve lives.