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Job ID :
47003BR
Location :
Singapore - Marsiling
:
Job Description

Job description:

  • Provide sustaining engineering support to develop and improve manufacturing process
  • Provide engineering support to improve product manufacturing first pass yield
  • Support RnD and production to develop manufacturing test tooling and fixtures
  • Perform engineering evaluation to support alternate component or part qualification to mitigate component or part end of life (EOL) concern
  • Perform manufacturing process validation (IQ/OQ/PQ) for new manufacturing line and test fixture setup.
  • Participate in production daily meeting to resolve instrument assembly and testing failures.
  • Maintain and ensure systems and procedures are in compliance with ISO, Regulatory and housekeeping
  • requirements.
  • - Plan and execute activities with other department to ensure common goals are met.

Requirement

  • Bachelor of Science in Mechanical Engineering with minimum 3 years of experience in a BioTech or Medical Instrument manufacturing environment.
  • Good knowledge of GMP and ISO13485 requirement
  • Ability to perform failure investigation independently
  • Good analytical skills and ability communicate effectively with all band level
  • Understanding of ISO9001, ISO13485, ISO14971 and 21CFR Part 820 requirements.
  • Laview programming experience will be an added advantage


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