SunnyvaleRecruiter Since 2001
the smart solution for Sunnyvale jobs

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.
Responsibilities:

  • 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.
    Qualifications:
    • 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.
      Preferred:
      • 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds