NPI Engineer (Medical Device)

Klang, Selangor, Malaysia
Posted 1 month ago

JOB RESPONSIBILITIES:

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

JOB REQUIREMENTS:

  • 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.
Apply for this position
A valid email address is required.

*Required fields

Read More: You are free to provide consent, however such consent is necessary if you wish to receive trade information. You have the right to withdraw your consent at any time. If you withdraw your consent, we will not send trade information. You have the right to access personal data, rectify, delete or limit their processing, the right to objection, the right to transfer data, the right to lodge a complaint with a supervisory authority. The joint controllers are companies from the Steri Pack Group indicated below: 1) Poland: SteriPack Medical Poland sp. z o.o., Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice, 2) Ireland: National Science Park, Dublin Road, Petitswood, Mullingar, Co. Westmeath, N91 TX80, Ireland, 3) US: 4255 S. Pipkin Road, Lakeland, Florida 33811 , 4) Malaysia: Lot 119992, Jalan Canang Emas 8, Telok Gong Industrial Estate, Klang 42000, Selangor. Withdrawal of consent for one of the companies means the withdrawal of consent for the whole SteriPack Group. Offers will be submitted by a company from the Group that best suits the expectations both in terms of location and other conditions established during the communication taking place on the basis of the granted consent. Please find more information on the steripackgroup.com, the „Privacy Policy“ tab.