• Instrumental in the company's China Joint Venture formation and integration.• Developed a multi-million-dollar collaboration contract.• Introduced a collaborative international research alliance.• Developed (inception to NMPA approval) a "Made in China – For China" product and production line. A successful launch led to a significant sales increase.• Led a global product cost reduction program, saving 15% of total COGS.• Developing global engineering programs, development agreements, training, and R&D projects.• Orchestrating engineering work, service operations, regulatory and registration activities, productquality, production, cost reduction, and local sourcing.• Oversaw construction and certification of a 50,000 ft2 production plant and a training center.• Consistent delivery on time, on budget, and on scope.

• Transformed Accuray's product testing.• Consistent on-time delivery, ever-improving (measured) product quality, and increasing efficiency.Reduced field defects by 50%. Cut testing cycle time and costs by 50%.• Led five teams of sixty (60) DQA engineers in testing the company's products.• Introduced tool-driven testing, test automation, and regulatory-focused testing suites.• Envisioned the use of cutting-edge, unique test tools, simulators, methods, and techniques, allowingcomprehensive coverage, quick execution, and better product quality.• Delivered ISO13485, FDA, SHONIN, and NMPA-compliant verification and validation campaigns.• Operations in California, Wisconsin, and China with in-house and offshore contracted resources.

• Provided quality, regulatory, and test services to global medical device, aerospace, and biotech clients.• Helped customers achieve compliance, reduced cost, effectiveness, and product quality.• Supported ISO-13485, ISO-9000, and AS-9100 compliance and audits, source inspection, FAI, softwaretesting, and reliability testing.• Led a large team of auditors, engineers, technicians, and support staff across the USA, Israel, and Canada.• Directed business development, sales, and marketing.

• Developed an FDA-Class V&V suite for a portable ultrasound system.• Achieved successful 510K approval.

• Managed the development of software and algorithms for the CyberKnife radiosurgery device.• Managed successful submission of the first 501K.• Designed the CyberKnife real-time X-Ray image guiding system.• Recruited and managed a team of imaging and algorithm experts, software developers, software qualityassurance engineers, and IT professionals.

• Developed software and hardware for SEMI capital equipment.• Led Integration and implementation of equipment at sites in Japan and Korea.