Manufacturing Engineer

Full Time
Milpitas, CA 95035
Posted
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 J&J 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

hcl_ers

Job Type: Full-time

Salary: $45.00 - $50.00 per hour

Benefits:

  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift

Work Location: One location

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