Philip Ketzel, MBA

Associate Director of External Manufacturing | Medical Device Manufacturing

Slippery Rock, Pennsylvania, United States

About

My role as Associate Director - External Supplier Management is to drive new product introductions and advance our market position. My expertise in medical device manufacturing is evidenced by successfully launching seven new products, enhancing our sales and market share within the Radiology sector. The competencies I bring are grounded in a Six Sigma Green Belt certification and a strong foundation in relationship building and capacity planning. My recent achievements include steering a project that is projected to save $5 million annually through strategic supply chain optimization and integrating a clear-to-clear laser welding process that escalated production fivefold. These initiatives not only reflect my commitment to operational excellence but also support Bayer's mission to deliver innovative medical devices globally.

Experience

  • Bayer (Full-time · 14 yrs 9 mos)
    • Associate Director of External Manufacturing
      Feb 2017 - Present · 9 yrs 5 mos

      9/08 – Present Bayer Pharmaceuticals Radiology New Product Introduction Manager - External Manufacturing Medical Devices 2/17 – Present ● Manage the technical interface and coordinate various functions within the organization to implement product or process changes at contract manufacturers domestically and globally for electromechanical and sterile disposable devices, including, but not limited to, injection molding, extrusion, assembly, packaging, and sterilization. ● I will serve as the product supply point of contact, providing an overview of manufacturing and distribution from the early stages of the project. ● Lead and participate in technology transfers, new product launches, and validation activities with the CMO and internal cross-functional teams, including Device Engineering, Regulatory Affairs, and Quality departments. ● Led a continuous improvement project team to evaluate a clear-to-clear plastic laser welding process to increase the throughput and weld quality. In collaboration with the CMO and selected fixture supplier, the redesigned fixture and process provided a 25% reduction in cycle time and an increase in production of 33%. ● Lead and support the transfer of existing product technology to alternate contract manufacturers to mitigate potential risks associated with single-sourcing components and assemblies. ● Collaborate with internal cross-functional resources, including but not limited to quality, supply chain regulatory affairs, sterilization, and procurement to implement product and process changes for new and sustaining medical device products. ● Manage multiple new product medical device projects across several sites located across the globe, including but not limited to China, Germany, Australia, Mexico, and the United States. ● Managed a new product launch and product transfer project to a CMO, which will save an estimated 5 million dollars annually through supply chain optimization and vertical integration.

    • Project Engineer, Sustaining Tooling
      Oct 2011 - Feb 2017 · 5 yrs 5 mos

      ● Managed multiple tooling projects to support the Bayer Radiology sterile disposables and electromechanical businesses. Projects are managed from construction, supplier integration, and qualification activities of tooling as required. ● Implemented real-time remote monitoring technology on sterile disposable tooling to obtain tool performance data and understand tool utilization at contract manufacturers. The data provided by the monitors has been reviewed with the suppliers during business reviews and contract negotiations. ● Implemented cost savings projects of over $500,000 for 2015 by collaborating with suppliers to improve tooling efficiency. ● Implemented an end-to-end process for managing sustaining tooling projects with cross-functional teams throughout the Bayer Radiology business utilizing Six Sigma methodologies. ● Developed a database to manage all the Bayer Radiology tooling assets, which comprises 900 active tools, 150 materials, 100 suppliers, and over 1200 part numbers. The database provides a central location to record and retrieve tool and part information, such as tool capacity, component material, and maintenance information. The database is used to provide valuable information for contract negotiations and to mitigate supply risks. ● Generated capital appropriations requests to be presented to senior management to justify new tooling for capacity expansion, refurbishment, replacement, and savings initiatives. ● Supported investigations to resolve quality issues at contract manufacturers and tier-two suppliers. ● Partnered with finance to manage a $3.5 million annual capital tooling budget for Bayer Radiology Product Supply organization.

  • Sr. Tooling Engineer/Process Engineer at Medrad
    Sep 2008 - Oct 2010 · 2 yrs 2 mos

    - Developed a system to qualify and support production requirements of low volume injection molded components with the support of a cross functional team. - Managed the purchasing of steel, mold bases, mold components, and services received from external vendors. - Collaborated with external tooling vendors to increase capability and to meet cost and timing requirements. - Increased capability of the shop by instituting the use of hardened steel in tool designs where need to increase the longevity of the tooling produced. - Instituted a system for organizing and tracking tooling locations and raw material inventory. - Acquired and installed two robots to improve the utilization and capability of our injection molding lab. - Designed prototype injection molds to support new product development. - Sample new injection molds, and manage FAI and qualification activities of new and existing injection molded components. - Mentored and advised design engineers regarding product feasibility, tool robustness and potential problems with dimensional/tolerance capability and cosmetic defects. - Supported development of new processes such as over-molding, blow molding and extrusion, and co-extrusion. - Maintained, repaired and troubleshot injection molding presses and auxiliary equipment.

  • Process Engineer / Operations Supervisor at Delphi Automotive Systems
    May 2003 - Aug 2008 · 5 yrs 4 mos

    • Managed manufacturing employees, material, and equipment to meet scheduling and inventory requirements. • One of 12 Process Engineer/Supervisors responsible for managing the daily operations of 120 injection molding machines and 128 hourly employees across four crews. • Troubleshot injection molding processes, equipment, and plant system issues from raw material through shipped product. • Advised engineering support groups regarding part design, tool design, and processes in support of continuous improvement activities. • Conducted training and evaluations hourly production employees.

  • Tooling Engineer at Delphi
    Sep 2000 - Aug 2008 · 8 yrs

    -Coordinated design and build of new tools with outside vendors from late concept through release to production -Conducted hands on debug of tools at an onsite lab, also provided feedback and direction to outside vendors to correct problems -Supported continuous improvement activities with manufacturing organizations in Ohio and Mississippi to improve product quality -Received quotes from outside vendors on tooling revision cost and timing -Develop a strong understanding of tool building process and machining operations -Worked with internal departments and outside vendors to develop high quality tooling and components that would meet or exceed customer expectations in quality, lead-time, and cost -Supported tooling programs for two new World Class Injection Molding Facilities