System Verification & Validation (V&V) Engineer

Role: System Verification & Validation (V&V) Engineer
Work location: Hercules, CA (onsite)
Long term contract

Job Description:
Role Summary
Execute system-level V&V . Ensure requirements traceability, compliance, and objective evidence for design releases and sustaining changes.

Key Responsibilities:
Develop and execute V&V Plans, Protocols, and Reports.
Maintain requirements traceability and DHF documentation.
Perform hardware/software/lab tests;
Ensure compliance with ISO 13485 standards.
Communicate status and present evidence in reviews.
Implement and support test automation for regression and system-level testing.

Qualifications & Experience
Education:
o Bachelor's / master's degree in engineering (Electrical, Biomedical, Mechanical, Software).
Experience:
o 7-10 years in system-level V&V for IVD/medical devices or complex electromechanical systems.
o Experience in test automation.
o Hands-on protocol design and execution in regulated environments.

Preferred:
o Wet lab workflow knowledge; understanding of sample handling and reagents.
o Familiarity with ISO 13485, ISO 14971, IEC 62304.

Thanks & Regards,

Krishan Kumar Sr. IT Recruiter

Last Word Consulting Inc.

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Office: +1- Ext 405

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