James McInnis

Manager of Technology & Product Management at Caldwell Manufacturing Company
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Contact Information
Location
Hilton, New York, United States, US

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Credentials

  • Certified SolidWorks Professional 2007
    SolidWorks Authorized Training Centre
  • Crucial Conversations
    Cmc
  • Design For Six Sigma
    Cmc

Experience

    • United States
    • Building Materials
    • 1 - 100 Employee
    • Manager of Technology & Product Management
      • Jun 2022 - Present

    • Engineering Manager
      • Jan 2015 - Jun 2022

      Responsible for new product development of Hinge Products and company VA/VE activities.

    • Senior Product Engineer
      • Sep 2012 - Jan 2015

      Responsible for continuous improvement of all products and hinge product support.

    • Product Design Engineer
      • Nov 2008 - Sep 2012

    • Engineering Associate
      • Nov 2004 - Sep 2008

      Design, build and test new equipment and tooling for medical device manufacturing. Prepare engineering drawings through the use of CAD software. Assist in developing and executing equipment and process qualification (IQ, OQ, PQ) and verification protocols and reports. Write SOPs, work instructions, and supporting documentation. Adhere to design control procedures and maintain design history files.Participate on product and process risk analyses. Monitor operation and performance of manufacturing equipment and controlled rooms. Perform work related to planning, devising, or adapting methods to improve manufacturing efficiencies and ensure product requirements are met. Investigate manufacturing cost savings and suggest design and process improvements. Troubleshoot manufacturing related issues and take corrective action. Show less

    • United States
    • Biotechnology Research
    • Engineering Technician
      • Oct 2003 - Nov 2004

      This position supported the manufacturing process of sheet-metal products. Developed flat patterns of complex sheet-metal components using Solidworks and AutoCAD. Worked with customers to optimize their designs to be the most cost efficient. Assisted in the design of special tooling. Wrote and released engineering documentation. This position supported the manufacturing process of sheet-metal products. Developed flat patterns of complex sheet-metal components using Solidworks and AutoCAD. Worked with customers to optimize their designs to be the most cost efficient. Assisted in the design of special tooling. Wrote and released engineering documentation.

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Engineering Tech
      • Sep 2000 - Aug 2003

      Manufacturing / Engineering Technician at Abiomed: This position supported the new product initiation and the process development of the Abiocor artificial heart. Designed, assembled, and maintained process equipment used to build implantable medical devices. Processed all designs with the proper documentation required: such as Drawing packages, Installation Qualification / Operation Qualification, Failure Mode Effect Analysis, Preventive Maintenance schedule, and Operation and Process Procedure Manufacturing / Engineering Technician at Abiomed: This position supported the new product initiation and the process development of the Abiocor artificial heart. Designed, assembled, and maintained process equipment used to build implantable medical devices. Processed all designs with the proper documentation required: such as Drawing packages, Installation Qualification / Operation Qualification, Failure Mode Effect Analysis, Preventive Maintenance schedule, and Operation and Process Procedure

    • United States
    • Packaging & Containers
    • 1 - 100 Employee
    • Machinist / Mechanical and Electrical Technician
      • 1998 - 2003

      This position assisted in the design and building of Fluted Cup Machine, and other special application equipment. I troubleshot and repaired mechanical and electrical problems with all equipment. Created and wrote Lock-Out / Tag-out procedures. Also transferred paper drawings to AutoCAD and maintained the CAD systems along with the Director of Engineering. This position assisted in the design and building of Fluted Cup Machine, and other special application equipment. I troubleshot and repaired mechanical and electrical problems with all equipment. Created and wrote Lock-Out / Tag-out procedures. Also transferred paper drawings to AutoCAD and maintained the CAD systems along with the Director of Engineering.

Education

  • Rochester Institute of Technology
    BS, Mechanical Engineering Technology
    2006 - 2010

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