Validation Engineer

Designation: Engineer

Location: USA


  • Conduct user interviews, gathered requirements and analyzed the requirements.  
  • Create the Business Requirement Specification (BRS) and Functional Requirement (FRS) document for the system integration.
  • Produce, update, and maintain documentation including project plans and weekly status.
  • Prepare Verification & Validation Plan, aligned with business goals, defined, and prepared test cases and functional Verification & Validation test protocols.
  • Prepare Analysis document to identify the individual application impact on the instrument.  
  • Coordinate the implementation or scheduling of validation testing.
  • Generate test cases from requirements documents for medical instruments.  
  • Design the business requirement collection approach based on the project scope and SDLC methodology.
  • Design and develop Uses Cases & Create the Verification & Validation Protocols for the required modules in the project.  
  • Create the Requirement Traceability Matrix for the Test Case tracking.
  • Execute test cases and generate execution reports.
  • Documenting requirements for evidence gathering necessary for FDA 510K submissions.
  • Implement of 21 CFR Part 820 – Quality System Regulations and IEC 62304.
  • Conduct workflow, process diagram, and GAP analysis to derive requirements for existing systems enhancements.
  • Determine and develop test strategies for Functional Verification and User Acceptance testing. 

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