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Craig Breckenridge is a seasoned industrial engineer with expertise in medical devices, Six Sigma, Lean Manufacturing, and Quality System management. He has 20+ years of experience in product development, process improvement, and manufacturing, with a strong background in medical device design and development. Breckenridge has held various leadership positions, including Senior Industrial Engineer at Follett LLC, Draeger, and OraSure Technologies.

Experience

  • Follett LLC
    • Allentown, Pennsylvania Area
    • Senior Industrial Engineer
      • Oct 2015 - Present
      • Allentown, Pennsylvania Area

      As Sr. Industrial Engineer I was the Project Engineer for production cell redesign for corporate headquarters and was Team Leader for the Core Team that designed and directed changes to plant modifications.HIGHLIGHTS:♦ Managed capital appropriation for equipment resulting in safety, ergonomic & production improvements♦ Utilized Team Kaizen events to move six production cells for integration of new product launches for FDA regulated and non-regulated devices ♦ Directed contractors for installation and start-up of equipment♦ Used Inventor and 3D printing to develop prototypes and tooling for production support ♦ Evaluated, purchased and commissioned a helium leak detection system for refrigerant systemsimprovements

  • Draeger
    • Greater Philadelphia Area
    • Senior Industrial Engineer
      • Dec 2008 - Oct 2015
      • Greater Philadelphia Area

      I was hired at Drager in the Neonatal Open Care unit where I supported products on a global scale, supported customers and quality escalations as needed, and became heavily involved in product redesign and technical support for 510(k) approvals. After advancing to Product Owner of Infrastructure Projects, my core focus was the transfer and maintenance of an entire German assembly process to our Telford, PA plant. Both roles required strategic project management skills and an ability to maximize efficiency and profitability. NORTH AMERICAN PRODUCT OWNER - Hospital Workplace Infrastructure Projects(2012-2015) ♦ Developed building design layout using Auto CAD for all equipment and processes ♦ Coordinated the international transfer of German assembly process to the PA plant; managed all equipment installations, performed all validations and FMEAs for the new operation♦ Supervised production start-up and performed critical review and optimization of assembly processes NEONATAL OPEN CARE - Thermoregulation & Jaundice Management Global Product Owner(2008 - 2012)♦ Redesigned open care product for infants (design-to-cost project); reduced manufacturing costs via efficiencies and outsourcing♦ Technically supported 510(k) approval for infant ventilator and jaundice treatment devices♦ Improved production line & facility layouts; reduced space by 50%, increased efficiency by 15% ♦ Worked with machine shops to design and fabricate product and production support equipment

    • Manufacturing Engineer
      • Feb 2007 - Dec 2008
      • Bethlehem, PA

      Here, I developed facility improvement plans for two locations with project budget costs approaching $750K. Focused heavily on innovation as well as product and process design. ♦ Developed new medical device design using SolidWorks; generated SLA and managed prototype injection mold design♦ Contributed to rework of existing cryosurgical medical device plastic design using SolidWorks to meet changes in customer requirements; incorporated changes into injection mold redesign and include Risk Assessments, IQ, OQ and PQ of new process♦ Improved injection molding process for HIV medical device plastic housing; led team in development and installation of new packaging line for HIV diagnostic medical device; delivered on time and under budget♦ Designed, tested and commissioned production equipment for cryosurgical product line

  • Silberline®
    • Lansford, PA
    • Senior Production Engineer
      • 1988 - 2006
      • Lansford, PA

      Significant contributions to this chemical manufacturing company including management of pilot plant operations, scale-up, and production and process engineering. Senior Production Engineer (2005 to 2006)♦ Developed automated valve for rotating processing equipment facilitating an ergonomic breakthrough♦ Reduced volatile organic compound emissions by 70% and improved safety with design of several automated clean-in-place systems with pneumatic actuation♦ Realized annual savings of $70K by reducing maintenance downtime via Six Sigma improvement team♦ Trained supervisors in root cause analysis and process control systems♦ Improved safety record to below 50% of industry standard; accomplished by leading key ergonomic projects and uncovering safety deficienciesProcess Engineer (1988 to 2005)♦ Managed pilot plant for 12 years supervising up to four technicians on three shifts♦ Supported development and validation of computer simulation model using Arena software for manufacturing over 500 products run simultaneously in three multi-state locations on 22 production lines ♦ Engineered countercurrent liquid-liquid extraction system from concept through design, fabrication, pilot plant testing and into 12,000 gallon production system♦ Developed ion exchange process to remove 50% of the detrimental acids from process solvent♦ Served as international liaison between US and UK; traveled to coordinate process changes and new innovations

Education

  • 1989 - 1992
    Lehigh University
    M.S., Molecular Bioscience and Boitechnology
  • West Chester University of Pennsylvania
    Bachelor of Science - BS, Chemistry
  • West Chester University of Pennsylvania
    Bachelor of Science - BS, Biology

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Industry Focus. “Medical Devices”

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