As part of an R&D team, the Sr. Verification and Validation (V&V) Engineer will be responsible for leading the verification and validation activities for a new product system according to FDA requirements and internal quality standards. This role will support the Systems Engineering group and activities includes generating V&V protocols and reports, performing testing, data analysis, and participates in troubleshooting issues throughout the product development cycle. In addition, it is expected this role will support the traceability of the V&V results to the design input and output elements, document and maintain system configuration, and ensure that all test equipment are appropriately validated and controlled. This position will ensure that the project progresses as planned, and meets the project’s goals and deliverable per Abbott quality system. This position will work with a multidisciplinary team and external vendors to resolve V&V issues, engage in troubleshooting, and contribute to project development activities.
Essential Duties and Responsibilities:
•Primary lead for the V&V activities, and coordinate activities with other V&V members
•Define and develop V&V protocols based on design inputs.
•Perform testing, analyze results, resolve deviations, and generate V&V reports.
•Maintain and control configuration of systems and validated test equipment.
•Monitor progress via V&V plan, project schedule, and work with cross functional team.
•Supporting role for systems engineering, and requirements engineering activities.