Interim VP Manufacturing –Diagnostics and Medical Devices

  • Anywhere

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Summary

This interim VP of Manufacturing and Healthcare Operations has extensive experience with small to mid-sized medical diagnostic operations. This experience includes scaling up a start-up operation.. He has strong breadth of expertise ranging from assembly, engineering, manufacturing management, purchasing, inventory management, and maintenance. He is known for making fast progress with minimal resources and creating what is needed in a self-sufficient manner. This interim VP manufacturing of Diagnostics holds a dozen process patents related to diagnostic manufacturing and is considered a thought leader.

Highlights
• Diagnostic Manufacturing Scale-Up
• 12 Diagnostic Process Patents
• Strong Forecasting and Budgeting Skills
• Exceptional track record of meeting budget and timing requirements
• Lean / Six Sigma
• Continuous Improvement
• Process Innovation
• Integrated Functional Knowledge and Experience – Capable of driving progress from purchasing through distribution.

Relevant Accomplishments

  • Led the manufacturing scale-up for a point-of-care Diagnostics company developing an accurate, small, low-cost, and convenient in-vitro diagnostic device suitable for use in a doctor’s office or clinic for the rapid detection of the cause of respiratory infection, periodontitis, gastrointestinal diseases, urinary tract infections and sexually transmitted diseases; Inventor and Co-Inventor of entire IP estate.
  • Developed hardware, fluidics design and novel solutions for a point of care testing cartridge system
  • Developed advanced additive manufacturing strategy and process for novel use of 3D printed parts in the development and testing process.
  • Developed fully automated LFA Reel to reel process.
  • Developed and implemented innovative automation solutions for high volume manufacturing and assembling consumable devices and fine reagents used in the device. Used lean techniques and set KPI’s for all processes.
  • Developed, implemented and maintained FDA, USDA and ISO compliant Quality Management System from scratch.
  • Designed value mapped production flow to minimize steps and remove bottlenecks to maintain low JIT inventory.
  • Managing manufacturing and engineering meeting budget and other operational and financial objectives for a $140MM Medical Diagnostic Device manufacturer.
  • Developed replacement of plate handling robot. The new solution resulted in a 30% COGS reduction ( over $1MM annually)
  • Phase leader in new product introduction / releases for XYP V2, LX200, Flexman 3D, Magpix, LX100E, Luminex IS Software, IS 2.3 IVD release, XPonent, and NextGen BSD300 punch.
  • Implemented Lean Production principles and continuous improvement methodology.

Roles

    • VP of Manufacturing
    • Director of Operations
    • Director of Instrument Manufacturing and Manufacturing Engineering
    • VP Manufacturing
    • Maintenance Manager
    • Operations / Project Engineer

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To apply for this job email your details to dmagnani@maexecsearch.com