Verification and Validation Engineer
Verification and Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Title: Verification and Validation Engineer (V&V Engineer)
Location 10808 Willow Ct San Diego CA
Expected Start Date: 02/03/2025 End Date 11/02/2025 (Possible extension for long term)
Hours Per Day: 8.00 / Per Week: 40.00
Job Description
The Engineer Verification and Validation (V&V) will be engaged in verifying and validating product designs according to FDA requirements and internal quality standards.
Will provide input to what is required to show compliance including the amount of data required and the methodologies for collecting and analyzing the data.
Ensures that the data is collected using devices and software of appropriate recorded configurations performs the required analyses and documents work to meet standards and project delivery commitments.
Primary responsibilities for role:
- Works closely with Systems Engineering Project Management Marketing Quality and Regulatory personnel to verify and validate products. Implement project verification and validation strategies by defining and delivering verification and validation project deliverables.
- Work with project teams to create review and approve verification and validation deliverables.
- Review use cases and requirements for products to ensure that requirements and specifications can be verified and validated including risk mitigations usability and regulatory requirements.
- Work with product development teams to understand the product configurations being developed. Identify the data that will be required to show objectively that all configurations of the product meet their requirements as well as the customer needs.
- Define and develop test systems in the lab. Ensure that all test systems and equipment are appropriately validated and controlled.
- Perform verification and validation testing. Review and analyze test data and record pass/fail results and conclusions.
- Ensure that testing and results are traced to requirements. Track and report on progress toward completion of verification and validation.
- Summarize the verification and validation performed the data reviewed and conclusions reached. Project deliverables may include producing and/or reviewing verification and/or
- validation plans protocols and reports; execution of the plans and protocols; and resolving deviations.
- Manage timeline for verification and validation activities and provide updates to project teams.
- Support systems engineering teams in the completion of development testing to characterize designs and understand tradeoffs.
Additional Responsibilities:
Completion of verification and validation plans protocols and reports within assigned target dates including oversight of testing activities. Successful execution of study protocols. Successful management of V& V related activities and timelines associated with completion of Projects.
Knowledge Skills and Abilities:
- Experience executing verification and validation plans and protocols. Experience with requirements management riskbased testing approaches defect tracking and configuration control tools. Understand good engineering practices and test methodologies. Demonstrated capability to solve technical and scientific problems.
- Medical equipment or other equipment experience involving complex multicomponent systems including lab automation. Familiar with engineering process improvement methodologies Manage multiple tasks and priorities simultaneously and adapt to changes in program priorities Excellent communication and interpersonal skills
Education:
- Minimum requirement: Bachelors Degree in a technical discipline such as Engineering (Computer Electrical Chemical etc) Life Sciences or equivalent.
- EXP: 5 yrs experience in verification or validation 1 yrs experience with product development or GMP
Employment Type
Full Time
