BioMed SA seeks to accelerate growth of the healthcare and bioscience sector, create regional economic benefit, and contribute to the the health of San Antonio and beyond by establishing San Antonio as a leader in healthcare and bioscience.

• 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.

• Generated contracts to achieve gross revenue in excess of $600,000 in Year 2.• Follow-on contracts from 5/6 customers due to successful management multidisciplinary project teams to meet clients’ project goals.• Assisted clients with ISO 9001 and ISO 13485 quality system development and development meeting 21 CFR Part 820 and IEC 60601.• Performed critical administrative functions, including: web site development, marketing, contracts, and accounting. • Wrote SBIR grant applications for external clients.

Developed and implemented marketing strategy; generated budgetary estimates and wrote technical proposals to obtain funding ($1-3M/yr); managed multi-disciplinary technical projects; technical lead on multiple projects; developed research programs; supervised staff.

Managed projects; performed mechanical engineering and design activities for classified and medical device projects.

Manufacturing engineering of existing and new GPS products. Designed line layouts, assembly equipment, fixturing, and test equipment. Monitored and addressed production and returned product quality issues. Wrote assembly and test procedures. Managed new product launch activities.