USA and international regulatory clearance, vigilance, and quality control leadership for privately held cardiac device company. Pivotal trial underway in Europe, Canada, Australia, Japan and the USA. The Corvia Atrial Shunt is demonstrating significant symptom improvement for heart failure patients with elevated left atrial pressures.

Co-founder, Clinical and Regulatory Affairs Manager for MitraSpan, a venture-backed company investigating new approaches to micro-invasive structural heart repair surgery. Achieved EU CTAs and FDA early feasibility IDE. Treasurer of the corporation.

Quality Assurance and Regulatory Affairs for a privately held therapeutic device company. Established design controls. Achieved 510(k) market clearance for soft tissue ablation. Led pre-clinical research for cardiac ventricular ablation therapy.

Clinical, regulatory, quality, and manufacturing operations management for a venture-backed percutanous mitral valve repair company. Clinical research (in 7 languages) & ISO 13485 certificate.

Manufacturing section manager & process development engineering manager for medical ultrasound transducers. 24 x 7 operations and three engineering teams. During 19 years with HP Medical I built the ultrasound transducer operations into a major technical contributing team. Cross functional assignments included R&D manager for medical equipment customer service (field operations) & executive program manager for HP / Agilent split of international internal / commerce software operations.