Sr. Medical Device Engineer
Current● Designed a regression verification and validation strategy of a substantial change to an existing product. Successfully implemented verification, validation, and shelf life testing strategy through risk documentation review, facilitating collaborative discussions, and driving cross functional actions to completion. Successfully reduced quantity of tested parts by over 50% without sacrificing the robustness of the verification.● Weighed concerns and requirements from Operations, Regulatory Affairs, Quality Engineering, and Program management to create robust verification and validation strategies while optimizing effort and cost needed to execute strategies.● Leading initiative to automate verification test methods to improve value of testing outputs while reducing effort of testing. Establishing a phase gate approach for implementing and sustaining automation technologies. Using design tools to create measurable scales for the value and effort for each technology.