Job Title: System Verification & Validation (V&V) Engineer Location: Hercules, CA
Duration: 3 Months (CTH) *Send me the resumes to [email protected] <[email protected]>* *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." -- You received this message because you are subscribed to the Google Groups "Powerbuilder Assignments" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To view this discussion visit https://groups.google.com/d/msgid/powerbuilder-assignments/CALBV6XwvtZF5vFgoou1YELmtsOKmr92kKVmLZ0z_6DwEJDkfZQ%40mail.gmail.com.
