New Product Introduction Specialist

3 days ago


Klang, Selangor, Malaysia SteriPack Group Full time

We are seeking a highly dedicated Senior/NPI Engineer to manage new product introduction projects, involving process development, reverse engineering, product transfer, validation, and verification activities in our Medical Device/Pharmaceutical sector.

Key Responsibilities:
  • Manage NPI projects based on customer requests, ensuring timely delivery and quality standards.
  • Evaluate and manage customer/supplier change requests, converting them into internal specifications.
  • Develop specifications of new products according to customer requirements, taking into account regulatory compliance.
  • Establish the specifications for new products, sustaining changes, and raw materials, maintaining a strong focus on quality and safety.
  • Design, establish, validate, and implement new manufacturing processes (automated, semi-automated, and manual), optimizing efficiency and productivity.
  • Design tools/dies/jigs/fixtures for manufacturing processes, ensuring precision and accuracy.
  • Prepare the Bill of Materials for new materials, streamlining procurement and logistics.
  • Assist in process cycle time calculation and line balancing for new manufacturing lines, enhancing production capacity.
  • Establish new test methods for raw material and product inspection, guaranteeing quality control.
  • Prepare required documentation & work procedures for the manufacturing of new products/processes, ensuring regulatory compliance.
  • Support technical challenges from daily operations, providing expert guidance and solutions.
  • Assist in validation and process improvement activities in production, driving continuous improvement.


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