Description
Job DescriptionThe Engineer, Verification and Validation (V&V) will be engaged in verifying and validating product designs according to FDA requirements and internal quality standards. The incumbent 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. The incumbent 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.Major Activities:
* Works closely with Systems Engineering, Project Management, Marketing, Quality and Regula-tory 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 specifica-tions can be verified and validated, including risk mitigations, usability and regulatory require-ments
? Work with product development teams to understand the product configurations being devel-oped
? 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 including 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 trade-offs.
Minimum requirementsEducation:
* B.S. degree in Computer, Engineering or related sciences degree.
Experience:
* 8+ yrs experience in design verification or validation
* 4+ yrs experience with product development per FDA design control and ISO13485
* Experience creating verification and validation plans, protocols, and reports
* Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools
* Understand good engineering practices and test method-ologies
* Demonstrated capability to solve technical and scientific problems
* Medical equipment or other equipment experience involving complex, multi-component systems, including lab automation
* Experience with automation tools for testing applications
* Familiar with engineering process improvement method-ologies
* Manage multiple tasks and priorities simultaneously and adapt to changes in program priorities
* Excellent communication and interpersonal skills
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