Medical Device Executive with proven leadership in New Product Development, R&D, Commercialization, and Project Management. Consistently executes product launches on budget and on schedule. History of demonstrable contributions to Business Development, Marketing, Portfolio Management, Production, and Revenue Growth.
Cardinal Health (Long Term Assignment through Randstand Engineering)CurrentQuality ConsultantLed Quality System integration of Cardinal Health acquired medical device companiesread more
Managed new product development...Led Quality System integration of Cardinal Health acquired medical device companies
Managed new product development project with $1MM budget and over 7 team members
Designed and Implemented ISO 13485 systems such as Management Review, Documentation, Training
Escorted internal and external auditors from BSI, FDA and Constructed corrective action response
Created multiple Spreadsheet quality tools and completed a software validation ERP project
Ninfa ConsultingCurrentPresident, Medical DevicesIndependent Consultant since 2009. New Venture (LLC) officially started in August 2013. Advising and Consulting of...read moreIndependent Consultant since 2009. New Venture (LLC) officially started in August 2013. Advising and Consulting of medical devices on Project Strategy, Execution, and Commercialization. Clients in US and International.