Medical Device innovator having broad based experience and a proven track record of executing strategic initiatives in product development, clinical development and project management. Hands on experience in product design, product development, manufacturing, business development, project management and clinical research. An effective collaborator with the ability to quickly refine, communicate goals to focus efforts efficiently on project execution. Interested in new product and clinical evidence development to support product market expansion. • Accountable for $17M global Clinical Finance for the Covidien Surgical business. Consistently maintained forecast accuracy of ±5% through the implementation of project management principals.• Designed and implemented the Corporate Covidien Investigator Sponsored Reach (ISR) Policy and Web Site.• Established strategic product development mapping for Covidien Surgical Solutions.• Led acquisition due diligence and analysis activities in Business Development.• Worked closely with independent surgeons to validate proof of concept product designs.• Managed medical device development projects from concept through product launch at Covidien Surgical Solutions. • Medical device design experience utilizing 3D CAD, FEA, DFM/DFA methodologies to reduce cost and product launch timelines.• Manufacturing engineering start-up development of process, tooling, supplier development and validation. Implemented automation projects to improve productivity.• Established VA/VE activities with external suppliers to improve cost and quality.• Implemented Lean manufacturing development system and methodologies.Specialties: Minimally Invasive Surgical Device Development, Investigator Initiated Clinical Research, Project Management.
Listed skills include Design Control, R&D, Fda, Commercialization, and 18 others.