Exp: 5+ years
**Key Responsibilities**
- Review **Software Requirements Specification (SRS)** and **Software Design Specification (SDS)** for testability.
- Develop **Verification Test Plans**, **Test Protocols**, and **Test Cases** following IEC 62304.
- Create and maintain **traceability matrices** linking:
- Requirements Test Cases Test Results.
Execute:
- Functional testing
- Integration testing
- Regression testing
- Interface testing (e.g., sensors, actuators)
- Perform **risk‑based testing** aligned with ISO 14971 hazard controls.
- Document **objective evidence** of verification activities for regulatory submission.
- Log, investigate, and track defects using the organization's QMS.
Ensure compliance with:
- FDA 21 CFR 820.30 (Design Controls)
- IEC 62304 (Software Life Cycle)
- IEC 60601-1/IEC 60601-1-6 (Usability considerations)
- Support audits and provide documentation to regulatory bodies (FDA, NB, internal QA).
MXW3G

📌 Validation Engineer (Tijuana)
🏢 W3Global
📍 Tijuana