Validation engineer (tijuana)

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). #J-18808-Ljbffr