Vp Operations
San Antonio, Texas Area
• Increased funding with powerful investor presentations and the successful completion of corporate milestones within schedules and budgets.• Decreased customer device malfunctions by 49% per clinical site through the implementation of a defect tracking system to drive Engineering to identify, track, and solve over 1500 design issues.• Decreased production cycle time by 43% through work flow improvements, improved testing, and design changes.• Optimized the supply chain to reduce the number of suppliers by 61%, using a new supplier selection process, commodity structure, performance metrics, quality evaluations, and implementation of a new ERP system.• Managed field service for 16 clinical sites (pivotal trial) and multiple other clinical trials in the US and Europe.• Changed R&D culture as Interim VP of Hardware Engineering, resulting in a development schedule improvement of 23%.• As interim QARA, authored sections and coordinated submission of PMA modules and subsequent FDA responses. Managed and participated in audits by regulatory bodies, including FDA. Optimized the Quality Management System, achieving improved development cycle times and a reduction in audit findings.• Led company through 2.5x staff growth; directly hired 16 staff, with 100% retention at 3 yrs.• Built new departments for: global manufacturing, international customer service, supply chain, corporate safety, inventory, and shipping.