• Experienced in New Product Development focused on the design quality and development within a Medical Device • Risk Management specialist, manage risk-based design verification process • Supplier development and supply chain management. Qualification using PPAP / Six Sigma Quality Tools.• Supplier development program resulting in 20 % decrease in component defects. Implemented Six Sigma methodologies, leading to a 15% reduction in manufacturing process variation• Performed gap analysis for risk files and complaints analysis. Bringing a variety of devices up to ‘state of the art’ for MDR compliance.

• Led Tissue Testing and analyzing data for LigaSure Instruments to evaluate the performance of the devices on sealing vessels.• Organized Pre-Clinical Chronic and Acute labs to collect necessary data on tissue for 510K submission of LigaSure Blunt Tip 5 mm devices.• Served as surgical assistant and interviewer for surgeon evaluation labs involving in vivo animal models and human cadavers using VOC tools.• Analyzed thermal spread data taken from pre-clinical lab to evaluate jaw performance for our LigaSure devices.• Routinely used Design for Six Sigma tools for statistical analysis of test data.• Managed R&D support in Thoracic Initiative Project. Developed Burst/Leak test setup to gather data using LigaSure devices in lung vasculature and parenchyma in pre-clinical and bench model testing.• Joint patent holder for developing the next generation Cool-tip product and Microwave antennas. Managed the effort to gather pre-clinical and bench model data and analyze it. The Surgical Testing Instrument and System was developed on the basis of these observations (Patent number 7,804,308).• Formed and managed a team to design a fixture to measure the di-electric properties of biological tissue at radio frequency (RF) range (Patent number 7,443,175).