Location
tijuana, baja california, Mexico
Posted
July 07, 2026
Job Description
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...