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Manufacturing Engineer

Company: Katalyst HealthCares & Life Sciences
Location: Milpitas
Posted on: May 28, 2023

Job Description:

Job Description


  • 5+ years' experience in Electrical or Mechanical engineering or equivalent
  • Exp in NPI/Advance Eng and On-Market product documentation
  • Exp in working manufacturing floor and capture documentation details
  • Change analysis/change order (ECN/ECO/CA/CO , etc) creation and track through approval process
  • IQ/OQ/PQ documentation and execution
  • Electrical OR mechanical Drawing edit (CAD Drawing in Solid works, Schematics in Altium/OrCAD) Solid works OR equivalent
  • Support Process Validation, Equipment / Fixture Qualification and Component Qualification activities
  • Process quality system documentation, Standard Operating Procedures ( "SOPs"), manufacturing instructions as well as other types of documentation releases such as DHFs.
  • Component obsolescence management as needed
  • Good understanding on medical standards and medical product development life cycle
  • Familiarity with Pharmaceutical process is plus
  • Manage design history files process by: reviewing and releasing on the Agile System Certificates, Design Reviews, BOM, Confidential Documents, Protocols, Validations,
  • Verifications, Purchase Request for Parts, Test Reports, Software Documents, and Technical files

Keywords: Katalyst HealthCares & Life Sciences, Milpitas , Manufacturing Engineer, Engineering , Milpitas, California

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