V&V Engineer

Hercules, CA, US • Posted 30+ days ago • Updated 5 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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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 30+ days ago
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