Dayami Lopez
Senior Engineer Project Manager Senior Product Development Project Management Specialist @Medtronic
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WORK HISTORY
Senior Engineer Project Manager Senior Product Development Project Management Specialist @Medtronic
I oversee and manage operational aspects of new product development projects and initiatives within the Mechanical Circulatory Support (MCS) Advance Product Development (APD) Group. I serve as the project manager in the execution of New Product Development (NPD) projects. I lead the full lifecycle of requisite projects, including all design control activities and worked with cross-functional project teams to lead project activities and continuous improvement initiatives to drive better execution of NPD projects. I directly influence project strategy, teams, and stakeholders to ensure project milestones are achieved. I support overall project management infrastructure (metrics, reporting, administration, business reviews) and participate in implementing best practice tools and techniques in project management. I introduced team member recognitions for excellent work performed. Outflow Graft Project (yarn and gel changes): After a forced change in yarn and gel material and supplier, I led the team to obtain regulatory approval and launch product prior to exhausting the supply of the original components. The project was launched worldwide before complete inventory exhausted. Corrective and Preventive Action - Quick Connect of Outflow Graft (CAPA00280): I resolved a problem concerning closing CAPA open for many years to ensure regulatory approval from FDA and BSI for product launch. • I led critical projects to ensure supply to various markets prior to run-out dates, such as Vascutek Yarn & Gel change, TPI and Polo material change, Greatbatch mechanical changes, and Tubular polyester material change. • I led CAPA projects from investigation phase through implementation • I ensured each project was implemented according to CRHF Design Controls for projects submitted with legacy Design Controls procedures at time of submission to Regulatory agencies. • I collaborated with the logistics department for implementation of design changes prior to inventory runout.
EDUCATION
Florida Atlantic University
Executive MBA, Business Administration, Management and Operations
Florida International University
Bachelor's degree, Industrial Engineering
ABOUT DAYAMI LOPEZ
Over the last 20+ years I\'ve built a successful and fulfilling career in Product…
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