Pleasanton, California, United States
Results driven leader with experience in Executive Management, Engineering, Operations, Quality and Regulatory. Over Twenty years of experience focused on developing successful and challenging medical device technologies. Proven ability to work in a fast-paced environment while effectively interfacing with management and staff to drive various initiatives. Strong work ethic, positive team player, self-motivated with a commitment to excellence.
A novel IVD technology company focused on optofluidics to provide systems and solutions to advance the detection, diagnosis, monitoring, and treatment of disease using advanced photonics, MEMS, engineering, assay development, and reagent manufacturing excellence.
Hearing health start-up focused on the development of proprietary “custom” direct-drive technology, joined the company pre-Series A as the first operations employee reporting directly to the CEO. Developed and executed strategic operational objectives from the ground up to successfully achieve the clinical study, regulatory 510k approval (class II), commercial launch and scale-up. Designed and manufactured custom highly complex miniature electro-mechanical assemblies.
Early-stage start-up focused on the development of Drug Coated Balloon (DCB) technology, high sense of urgency to stabilize processes and equipment, establish new facility, hire and develop operations personnel, produce 10k devices to support the clinical study, PMA submission and EU commercial launch within 12 months.
Leader in minimally invasive treatments for Ear Nose and Throat (ENT), pioneered the field of Balloon Sinuplasty as a treatment for chronic sinusitis. Joined early stage (ExploraMed incubator) start-up as employee number nine. Developed and executed strategic operational objectives from the ground up, promoted to the executive team as Vice President of Quality in 2007 – 2012.
Established global quality policies and strategies to achieve compliance and business objectives, reported directly to the President, and collaborated cross-functionally with the executive team.
Responsible for the ground-up strategic planning and implementation of operational capabilities. Successfully led cross-functional teams through product development, stabilization, and transfer to achieve the company’s first commercial launch of thirteen products within seven months. Established in-house manufacturing capabilities to support seven product lines. Accomplished within three months, achieving 98% FPY. Located site, developed facility layouts, managed build-out of ISO Class 8 CER, offices, Engineering lab(s), anatomy training lab, warehouse.
Percutaneous vascular surgery devices, which surgically close the arterial access site in the femoral artery after catheterization procedures, such as angioplasty, stenting, atherectomy, and diagnostic angiography. Responsible for the strategic planning and implementation of engineering and quality initiatives. Areas of responsibility included manufacturing engineering, equipment development, process development, plastics engineering, process validation and production support.