Job Title: System Verification & Validation (V&V) Engineer
Location: Hercules, CA
Duration: 3 Months (CTH)
Send me the resumes to Venu.e...@infosharesystems.com
Job Description:
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.
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."
What are the Mandatory skills and skill proficiencies required for this position?
"System-level V&V for IVD/medical devices or complex electromechanical systems - 5
Test automation - 4
What are the Optional skills and skill proficiencies for this position?
"DHF documentation
Wet lab workflow knowledge; understanding of sample handling and reagents.
Familiarity with ISO 13485, ISO 14971, IEC 62304."