Investment diligence and project management in the medical device field.

Led continuous improvement and the development and scale-up prep for the next generation insulin infusion device.• Implemented capital programs to provide pilot scale and proof of concept high-volume manufacturing capabilities.• Directed improvements to company’s flagship product and enabled successful longer term clinical trial.• Communicated company operations strategy in numerous financing engagements and diligence reviews, leading to $100M series C financing.

Achieved value creating milestones while leading Product Development, Manufacturing, Quality, and Admin functions for start-up medical device company.• Led completion of product development for first generation PaQ, a disposable insulin delivery device. • Guided operation to successfully complete first clinical trial for insulin infusion pumps in type 2 diabetic population using continuous glucose monitoring.• Achieved CE mark, European Regulatory approval for PaQ.

Created Manufacturing, Quality, HR, IT, and Accounting functions for start-up company.• Established greenfield pilot manufacturing facility and Manufacturing, Quality, and Product Development teams.• Established quality system and attained ISO13485 QS certification in nine months.• Implemented Six Sigma programs to greatly reduce manufacturing variation, enabling products to meet specifications.

Led Manufacturing and Quality functions at 10 contract manufacturing facilities in Europe and North America, totaling 1800 people and $250M in revenue covering a wide variety of manufacturing technologies.• Reorganized operations, leveraging scale and eliminating 30 positions, saving over $2M annually.• Led the transformation of Mexican operation, including the introduction of more than 60 new products and scaling production on two PMA approved products, while improving fill rate by 25%.• Managed manufacturing technologies, including machining, stamping, metal and plastic injection molding, metal tubing manufacturing, wire grinding and coiling, and finished goods assembly.• Implemented company-wide quality programs, which reduced complaint rate by 35%.

Championed the continuous improvement of the vertically integrated manufacturing and logistics of Smith & Nephew joint repair products, including disposable and reusable instrumentation and implants.

Led company’s manufacturing and logistics functions, reporting to the CEO.Significantly improved manufacturing cost and quality through periods of high sales growth with superior service levels.

Managed 45-person, cross-functional operations unit responsible for the production and repair of medical endoscopes, including new product introductions and operational continuous improvement.