Position Description

Manufacturing Engineer (Medical Devices, West)
Job Code 15501
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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Responsibilities

  • Monitoring and evaluate plastic injection mold performance at vendor site, and lead the project to develop new mold for capacity expansion and replacement from design until qualified for mass production.
  • To troubleshoot injector defects potentially related to injection molding production occurring at vendors’ manufacturing sites, drive solutions with data analysis and fact-based approach
  • Work as project leader, coordinate between R&D and mold maker, develop new mold from prototype stage until mass production stage.
  • Work with in-house manufacturing and quality team collaboratively to qualify new tooling.
  • Compile tooling and molding related documentation in accordance to the regulatory requirement and keep the high-quality standard of molded components.
  • Initiate change control submission and review, conduct risk assessment, draft and get validation plan, validation protocol and report reviewed and approved based on the project master timeline.

 

Requirements

  • Degree in mechanical or chemical engineering field related to plastic injection molding, or diploma in engineering with more than 5 years’ experience in medical device/ pharmaceutical industry
  • Min 3 years of hands-on experience in Design for Manufacturing (DFM) for product and tooling design optimization.
  • Technical experience in medical device/ pharmaceutical industry, and familiar with ISO13485 requirements for IQ/OQ/PQ validation.

Contact Person: Wong, Tiing Hua - Reg No:R1328106 (tiinghua.wong@gmprecruit.com)

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