V&V Engineer

Hercules, CA, US • Posted 6 hours ago • Updated 6 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Verification And Validation
Requirements Traceability
Documentation
Computer Hardware
Regulatory Compliance
Regression Analysis
Testing
Electrical Engineering
Biomedicine
Mechanical Engineering
Medical Devices
Electromechanics
Automated Testing
Workflow
ISO 13485
ISO 9000

Summary

Job Summary:

The System Verification & Validation (V&V) Engineer is responsible for executing system-level verification and validation activities to ensure requirements traceability, regulatory compliance, and generation of objective evidence for design releases and sustaining changes in regulated medical device environments.

Roles & Responsibilities:

Execute system-level Verification & Validation (V&V) activities.
Develop and execute V&V Plans, Protocols, and Reports.
Maintain requirements traceability and Design History File (DHF) documentation.
Perform hardware, software, and laboratory testing.
Ensure compliance with ISO 13485 standards.
Communicate project status and present objective evidence during design and review meetings.
Implement and support test automation for regression and system-level testing.

Education & Experience:

Bachelor's or Master's degree in Engineering (Electrical, Biomedical, Mechanical, or Software).
7-10 years of experience in system-level V&V for IVD/medical devices or complex electromechanical systems.
Hands-on experience in protocol design and execution in regulated environments.
Experience in test automation.
Preferred experience with wet lab workflows, including sample handling and reagents.
Familiarity with ISO 13485, ISO 14971, and IEC 62304 standards.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 49c10df7a9039ef339a00819132dc14a
Posted 6 hours ago

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V&V Engineer

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Job Details

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