Medical Device Innovation Lead

5 days ago


Klang, Selangor, Malaysia SteriPack Group Full time

The SteriPack Group is seeking a skilled Senior/NPI Engineer to spearhead new product introduction efforts, emphasizing process development, reverse engineering, and product transfer within our Medical Device/Pharmaceutical sector.

Key Responsibilities:
  • Lead NPI projects from conceptualization to launch, aligning with business goals and customer expectations.
  • Identify and address potential risks associated with customer/supplier change requests, ensuring minimal disruption to operations.
  • Develop comprehensive specifications for new products, considering customer requirements and industry regulations.
  • Maintain accurate and up-to-date specifications for new products, raw materials, and processes, prioritizing quality, safety, and regulatory compliance.
  • Design, implement, and validate innovative manufacturing processes, leveraging automation and technology to boost productivity and efficiency.
  • Design and produce tools/dies/jigs/fixtures, driving precision and speed in production.
  • Streamline Bill of Materials creation for new materials, enhancing supply chain efficiency.
  • Optimize process cycle times and line balancing for new manufacturing lines, maximizing output and reducing waste.
  • Develop and execute rigorous test methods for raw material and product inspection, ensuring quality standards are met.
  • Publish necessary documentation and work procedures for new products/processes, ensuring regulatory compliance and knowledge sharing.
  • Foster collaboration with cross-functional teams to address technical challenges and drive operational excellence.
  • Contribute to ongoing validation and process improvement initiatives in production, driving innovation and best practices.


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