Ambu is currently looking for a Lean/Continuous Improvement Engineer to be based in Ambu Global Hub, Penang.

Key responsibilities 

• Lead CAPA in customer complaints for NPD and lifecycle products. 

• Perform risk assessment and identify immediate actions including scope and consequence. 

• Drive and conduct technical investigation and determine the root cause of product failures in NPD and lifecycle projects.
• Compose technical or problem-solving report and/or presentations to communicate findings and proposed solutions. 

• Collaborate within Project team, manufacturing, QA and other stakeholders to identify and align the appropriate solutions to correct product failure and prevent recurrence.  

• Develop new failure analysis method, best known method, processes and tools to improve the failure analysis process. 
• Participate and share inspiration of possible root cause to NPI / Production Process Engineering Team and propose root cause analysis method on failures related to production processes.
• Drives newly launched product improvements using Lean methodologies to continuously improve efficiency, reduce waste and increase customer satisfaction.
• Collaborate with Project Team to generate lessons learned and identify opportunities for improvement on newly launched products.
• Monitor and analyse production performance data to identify opportunities for improvement on newly launched products.
• Conduct production cycle time studies as early as pilot runs or pre-production builds to optimize processes and improve manufacturing efficiency.
• Drive and collaborate with Manufacturing and NPI team to develop an effective production layout to increase productivity, reducing costs and enhancing overall efficiency for new products.
• Stay updated on industry trends and best practices in continuous improvement and lean manufacturing.

Suggested candidate profile 

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you: 

• Bachelor’s degree in Mechanical, Chemical or Material Science or any equivalent engineering field.  

• Minimum 3years to 5 years of proven experience in failure analysis, utilizing Lean manufacturing initiatives preferably in a manufacturing or product development environment. 

• Good problem-solving skill and analytical skill with ability to identify the root cause of failures. 

• Good knowledge in problem-solving root cause analysis tools (e.g. fishbone diagram, 5 whys analysis). 

• Good knowledge in statistical analysis using Minitab software. 

• Good knowledge in using failure analysis equipment, such as SEM/EDX, FTIR and other relevant analytical equipment is added advantage. 

• Ability to analyse complex manufacturing data and propose changes leading to improve manufacturing efficiency.

• Knowledge in CAPA and NCR process is added advantage. 
• Certification in Six Sigma and/or Lean Manufacturing is added advantage.

• Some years of experience in medical device industry.

• Ability to work independently with minimum supervision, structured and systematic. 

• Excellent written and oral communication skills, with ability to create and deliver presentations to both technical and non-technical audiences.