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Senior Manufacturing Engineer

Company: Lumicity
Location: Sunnyvale
Posted on: January 18, 2023

Job Description:

Senior Manufacturing Engineer / FDA Breakthrough Medical Device / CAD / NPI
Title: Senior Manufacturing EngineerLocation: Sunnyvale, CA
Company:They are a medical device company focused on addressing the already well-recognized shortcomings in treating cardiac rhythm disease through Cardiac Resynchronization Therapy (CRT).
Job Description:This Senior Manufacturing Engineer will make a direct impact in successfully manufacturing highly complex novel Class II & III electromechanical medical devices. You will design, procure, and qualify critical tooling, fixtures, equipment, and documentation to achieve high manufacturing quality and efficiency.

  • Design, develop, and implement fixtures and tooling to increase quality, capacity, reliability, and yields.
  • Responsible for the installation of new equipment, and setting up proper preventive maintenance and calibration plans.
  • Develop protocols and coordinate validation of equipment and processes.
  • Lead the design and development efforts for significant product and/or process changes.
  • Lead and conduct experiments utilizing DOE methodology and other design tools.
  • Work with Quality Engineers to investigate product/process failures and collaborate on developing immediate and preventive measures.
    • Bachelor's Degree in Mechanical Engineering or related engineering discipline.
    • 4+ years in a medical device manufacturing environment.
    • Working knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO13485.
    • Demonstrates proficiency in coordinating the design and development of equipment and fixtures.
    • Solid modeling/CAD/CAM experience is a plus (SolidWorks).
    • SPC (Statistical Process Control) knowledge.
      • Catheter, Active Implantable, and/or Class III Medical Device experience
      • New Product Introduction (NPI) experience
        Senior Manufacturing Engineer / FDA Breakthrough Medical Device / CAD / NPI

Keywords: Lumicity, Sunnyvale , Senior Manufacturing Engineer, Engineering , Sunnyvale, California

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