Tony Viole

VP Operations at Avicena
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Contact Information
us****@****om
(386) 825-5501
Location
Orange County, California, United States, US

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • VP Operations
      • Oct 2017 - Present

    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • General Manager
      • Feb 2015 - Feb 2016

      Full P&L responsibility (product development, regulatory, quality, manufacturing, human resources, and supply chain management for a 3D Dental Imaging (CAD/CAM) technology.- Completed move from Pasadena, CA facility to new facility in San Clemente, CA including reissuance of CA FDB license.- Led cross functional team to design freeze on second generation intra-oral 3D camera to improve use, reliability, durability, versatility and cost.- Formulated and implementing phase out strategy for the existing camera to ensure successful implementation of new design. Show less

    • Senior Director of Product Development and Operations
      • Sep 2010 - Jan 2015

      Responsible for transition from prototype stage to manufacturable product for a 3D imaging technology, quality system implementation and maintenance, design control, manufacturing, and supply chain management.- Developed, implemented and maintained quality system (including design controls) for Arges prior to acquisition by Sirona Dental Systems.- Working with research group, external suppliers and consultants came up with low cost, easy to assemble design that met performance criteria for the camera, computer and stand.- Developed manufacturing processes and fixtures and implemented capacity to build 150-200 cameras per month with external contract assembler.- Completed verification and validation testing and successfully launched product within 8 months of design freeze. Show less

    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Director of Research
      • Dec 2002 - Oct 2009

      Team leader for development of the Exeleras® system, with specific responsibility for the development of the Exeleras implantable blood pump; management of Orqis’ IP Portfolio; in-vivo and in-vitro research and testing; Mechanism of Action research.• Led cross functional team from concept through first clinical use of the Exeleras system in less than 4.5 years and a budget in excess of $5MM.• Successfully set-up and managed complex, difficult supply chain ensuring timely delivery of product with unique design requirements and cutting edge manufacturing processes.• Managed and led development of patent portfolio consisting of 22 US and 6 international patents in 21 different countries with 24 additional pending applications under budget and at a cost savings of approximately 35% with a total expenditure of less than $2MM.• In collaboration with experts developed and managed intricate in-vivo efficacy and safety models to complete required product testing needed for clinical release and regulatory submissions.• Developed a concise and clear message on the Orqis Mechanism of Action. Show less

    • Director, Product Development & Operations
      • Apr 1999 - Dec 2002

      Developed product requirements, sourced, led development and in-vivo testing of, and supported initial clinical use of an extracorporeal blood pump that was part of the Cancion® system used for the treatment of Congestive Heart Failure; managed IP portfolio.• Evaluated available pump technologies and sourced four different potential pumps for use.• Managed suppliers, completed development and design V&V testing on two pumps and supported initial trials resulting in the first clinical use of a magnetically levitated blood pump. • Managed, under budget ($200K), IP portfolio with 5 issued patents and 11 patents pending. • Developed and managed the in-house capability to perform in-vitro hemolysis testing realizing a $3K cost savings for each test performed (greater than $600K savings to date).• In collaboration with experts developed unique canine and bovine heart failure models to complete efficacy and safety testing required for clinical use and regulatory submissions.• Negotiated lease for and completed second facility move (5000 and 9900 sq ft) in three years. Show less

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Director, Integrated Solutions Resource Development & Operations (CardioVascular Group)
      • Jul 1996 - Nov 1997

      Responsible for identifying, developing, negotiating contracts for and delivering resources that assist hospitals/cardiac centers to improve program quality, competitive position and financial strength.• Identified and negotiated exclusive contracts with outside suppliers to provide cardiac centers with needed resources to enhance outcomes and reduce costs• Developed and delivered thirty-two products, associated training and promotional collaterals.• Contracts signed or in process represented greater than $20 million potential (50% increase).• Completed Harvard Business School course “Understanding the New World of Healthcare”. Show less

    • Director, International Sales & Marketing (CardioVascular Group)
      • Jun 1993 - Jul 1996

      Created and managed local team of 7 specialists to provide strategic direction, product training, sales support, and marketing for international specialists and distributors with full P&L responsibility.• Increased annual sales from $20 million to $55 million.• Participated on acquisition team of $5 million Latin American Company.• Developed and began implementation of five-year strategic plan to grow sales to $100 million.• Led activities associated with five product recalls over four months with only two lost accounts.• Successfully directed planning and execution of the first Global Sales Meeting (>500 attendees). Show less

    • Project Engineer (Bentley Division)
      • Sep 1983 - Mar 1996

      Responsible for research, development and production support for new and existing products.• Developed two new cardioplegia delivery systems and a dual use auto-transfusion system.• Managed six-month project to design and release a new heat exchanger for the company’s main product line (necessitated by an unfavorable $52 million patent judgment).• Received President’s Award.

    • Director, International Sales & Marketing (Bentley Division)
      • Jan 1988 - Jun 1993

      Responsible for management of distributor network and activities of international affiliates with full P&L responsibility, direct management of two Managers, two Export Specialists and one Secretary.• Increased annual sales to $20 million (representing 65% of the division’s operating income).• Increased productivity of Western U.S. Sales Region (five U.S. District Sales Managers).• Developed and implemented product specifications, launch strategy and associated sales and marketing materials for company’s first infant/pediatric membrane oxygenator.• Moved to Europe for six months to develop targeted account strategies resulting in the achievement of the European team’s financial objectives for the first time in five years. Show less

    • Product Manager (Bentley Division)
      • Apr 1986 - Dec 1987

      Responsible for new product development, product line management, communications, advertising, pricing, market research and competitive strategy for global business of a $2 million product line.• Identified and launched three new products and redefined existing offering resulting in a 50% increase in dollar volume.

Education

  • The Ohio State University
    BS, Arts & Sciences - Microbiology
    1975 - 1979
  • Arizona State University
    M.S., Chemical & Biomedical Engineering
    1980 - 1984

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