Senior NPI Engineer Medical Device

• Managing NPI project based on customer requests.
  
• Evaluate and manage customer/supplier change request and converting the customer request into internal specification.
  
• Develop specification of new product according to customer requirements.
  
• Establish the specification for new product sustaining changes and raw material.
  
• Design establish validate and implement new manufacturing process (automated semiautomated and manual).
  
• Design tools/die/jig/fixture for manufacturing process
  
• Prepare the Bill of Material for new material.
  
• Assist in process cycle time calculation and line balance for new manufacturing line.
  
• Establish new test method for raw material and product inspection
  
• Prepare required documentations & work procedures for manufacturing of new products / processes
  
• Support to technical challenges from daily operation.
  
• Assist in validation and process improvement activities in production
  
• Provide training to production staff for new process implementation
  

Requirements

• Degree/Post Graduate level education in Engineering or Science
  
• Minimum 24 years working experience preferably in manufacturing or medical industry
  
• Good knowledge in Project Management & Process/Product development.
  
• Familiar with CAD drawing/Solidworks
  
• Knowledge in statistical analysis
  
• 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