-Managed and directed manufacturing operation of the world’s only FDA approved total artificial heart in a cleanroom and controlled temperature/humidity setting.-Experience with FDA audits, NCRs, CAPAs, failure investigations, quality system, change management and regulatory compliance. -Worked in cross functional teams collaborating with engineering, quality, and regulatory consistently to keep lab operating effectively and solve problems logically and efficiently.-Worked with commercial department to adjust production schedule in real time to meet sales goals or unforeseen customer orders.-Worked with buyer regularly adjusting safety stocks and sourcing new vendors for supplies.-Led regular stand-up meetings, events and continuous improvement projects with measurable goals. -Coordinated preventative maintenance on existing and new production equipment, including routine calibration.-Implemented root cause and corrective actions to improve product quality as well as implementing a process to track first pass yield. -Improved efficiency and productivity by eliminating waste and production constraints by adding key equipment and reducing man hours.

*Supervised and trained incoming technicians*Was responsible for daily lab activities and helped plan manufacturing scheduling