Manufacturing Engineer
Posted on :
08-11-2022
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Job Description
Responsibilities:
- 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
Employment Type
Full Time
Key Skills
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