• Support advanced technology R&D for endoscope projects

Managed special projects for the new Sterilmed manufacturing outsource partner.

• Active member of the Sr. Leadership Team.• Led the Manufacturing, Materials and Logistics, Engineering, and R&D functions.• Led Quality and Regulatory functions prior to the Acquisition by J&J.• Managed three facilities with three shifts and over 400 associates.

• Active member of the Sr. Leadership Team.• Led the development and deployment of processes and equipment needed to reprocess and refurbish single use medical devices for re-use.• Supported the FDA 510(k) filings through testing and validations.• Implemented and maintained engineering and manufacturing processes needed to maintain ISO13485 certification and meet FDA requirements.• Managed the in-house biological testing function needed to support the reprocessing 510(k) submissions.

• Led the development and deployment of processes and equipment needed to reprocess and refurbish single use medical devices for re-use.• Supported the FDA 510(k) filings through testing and validations.• Implemented and maintained engineering and manufacturing processes needed to maintain ISO13485 certification and meet FDA requirements.

• Active member of the Sr. Leadership Team.• Led the Manufacturing, Materials and Logistics, Engineering, and Quality functions.• Managed a highly vertically integrated facility with over 100 associates.• Developed and launched configurable build to order capital equipment.• Interfaced with major customers to understand specific needs and support custom proposals.

Held several positions of progressively increasing responsibility over 15 years:Vice President of Outsourcing and Quality 2000 – 2001Vice President of Engineering 1997 – 2000Vice President of Engineering & Manufacturing 1995 – 1997Vice President of Engineering 1992 – 1995Director of Engineering 1988 – 1992Engineering Manager 1986 – 1988• Active Member of the Sr. Leadership Team.Directed engineering, new product development, manufacturing, materials, quality, technical service, and OUS out-sourcing.• Fueled a steady double-digit revenue growth rate.• Led efforts to receive 36 US patents and a total of 59 worldwide. • Managed company intellectual property matters.• Negotiated and secured a patent license for a new technology.• Managed $35M in outsourced product spends through partner factories in Asia, Italy, and Mexico.• Developed and implemented processes to manage product designs and drive significant improvements in quality through off-shore outsource partners.• Achieved numerous cost reductions through price negotiations with suppliers of outsourced products.• Led the technical due diligence and technology integration for two major acquisitions.