NPI Engineer (Medical Device)

Klang, Selangor, Malaysia
Posted 1 month ago


You shall responsible for all new customer projects implementations, product transfer, breakthrough or critical projects which involved significant redesign of product/processes and general project management matters at SteriPack, including:-

  • To assist in handling new customer projects implementations and general project management
  • To handle technical change for existing customers
  • To evaluate change request received from supplier and customer
  • To evaluate raw material and to set up raw material specification
  • To design suitable tools/die/jig for the manufacturing process
  • To establish a suitable test method for raw material and product testing
  • To establish the manufacturing process for new products/ technical change
  • To carry out a preliminary study for new products/processes
  • To establish validation protocols for new equipment and new processes
  • To assist in validation and process improvement activities in production for new products/processes
  • To approve new parts/ tool/ mould/ die/ jig to be utilized in the production for new products / processes
  • To approve the first piece sample from the production
  • To prepare required documentation & work procedures for the manufacturing of new products/processes
  • To develop specification requirements for new projects
  • To provide training to production staff for new process implementation
  • To understand and follow the quality system, observe safety and health measures maintained in the company
  • To carry out other work-related activities as requested by the Project Manager


  • Degree/Post Graduate level education in Engineering or Science
  • Minimum two year’s working experience preferably in manufacturing or medical industry
  • Familiar with CAD drawing/Solidworks
  • Knowledge in statistical analysis (preferable Minitab)
  • Knowledge of ISO 13485 and GMP is an advantage.
  • Proactive and willing to learn
  • Good written and spoken English and Bahasa Malaysia.
  • Computer skill – familiar with Microsoft Office.
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