Responsible for leading Global Quality’s Restructuring Program, Project Management Office (PMO), and Global Quality Systems Improvement Project Portfolio. Responsible for leading Corporate initiative to harmonize, lean, and improve two International Quality Systems. Responsible for leading Corporate Audit Readiness Program to resolve FDA Corporate Warning Letter.

Responsible for supporting Interventional Cardiology and Peripheral Interventions franchise team goals and project cadence through effective management of six Project Managers and their New Product Development teams

Project Manager of cross-functional teams responsible for bringing new medical devices from concept to full global launch. Accountable for programs’ execution, strategy, schedule, budget ($3-5M/yr), resources, financials, and reporting. Deliverables included Initial Concepts, Market and Product Specs, Pre-Clinical animal studies, Intellectual Property, Design Freeze and Verification, Process Development, Clinical Trials, Regulatory approvals (IDE, PMA, 510k), transfers to Manufacturing, launch inventory builds, full product launch into US and OUS markets, and post launch technical support to manufacturing and sales force. Design Engineer of several Emerging Technology Cardiology devices. Responsible for inventing and prototyping new device concepts, conducting market research, and proving technical and pre-clinical feasibility. Technical lead and decision maker for material selection and design specifications to meet functional, biocompatibility, sterility, manufacturability, Intellectual Property, and clinical performance requirements. Drove creation of Labeling and Directions for Use. Granted numerous US Patents.Manufacturing Engineer responsible for providing day-to-day technical support for established and new production lines. Responsible for yield improvement, process documentation, process development, technical problem solving, customer complaint follow up, and new product transfers into manufacturing.