Equipment Quality Engineer, Quality Systems

Company: Neuralink
Location: Fremont
Posted on: November 26, 2022

Job Description:

As an Equipment Quality Engineer at Neuralink you will be responsible for the inspection, calibration, testing, maintenance and documentation of sophisticated medical, sterilization, and histopathology equipment. You will collaborate with multi-functional groups to resolve calibration/maintenance issues, support non-conformance investigations, improve equipment reliability, review procedures, and minimize equipment downtime.
About you:

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• You find large challenges exciting and enjoy discovering and defining problems as much as solving them.
  
• You deliver. You may enjoy thoughtful conversations about problems and perfecting designs, but in the end, you know that what matters is delivering a manufacturable solution that works every time.
  
• You are a cross-disciplinary team member. You are excited to work with and learn from software, mechanical, electrical, materials, biological engineers, and neuroscientists. You are comfortable communicating across teams.
  
• Resourceful, flexible and adaptable; no task is too big or too small.
  
  Essential responsibilities:
  
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  • Performs scheduled and unscheduled inspections, calibration, maintenance and electrical safety tests of biomedical equipment and medical systems where applicable to maintain code compliance.
    
  • Develop and validate calibration procedures and measurement uncertainties for different kinds of electrical and electronic instruments and devices.
    
  • Authorize and maintain metrological standards, policies and guidelines
    
  • Review all equipment specifications and records information for completeness and appropriateness.
    
  • Review and approval of Calibration, PM, and IQ/OQ/PQ documents and reports.
    
  • Collect, report, review and maintain calibration and preventive maintenance performance data into LIMS (Laboratory Information Management System) .
    
  • Manage service providers to ensure scheduling in accordance with Cal and PM due dates; coordinates the testing, monitoring, and inspecting processes of equipment calibration and PM
    
  • Responsible for documenting the results of all inspections, maintenance and tests.
    
  • Must work collaboratively with all tool users (surgery, veterinary medicine, and histopathology staff) and internal regulatory staff
    
  • Occasional travel will be required to provide service support to other sites.
    
    Qualifications:
    
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    • Evidence of exceptional ability in a technical discipline.
      
    • 3+ years of hands-on experience in electronic instrument calibration method development, metrology and measurement techniques.
      
    • Thorough knowledge of scientific principles required (general SOPs, GMP/GLP and ISO regulations)
      

Keywords: Neuralink, Fremont , Equipment Quality Engineer, Quality Systems, Other , Fremont, California