Job Description
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R&D Failure Analysis Engineer
City:  Penang
State: 
Country:  Malaysia
Business Area:  R&D
Department:  New Product Introduction
Employment Type:  Full-time

Ambu is currently looking for a R&D Failure Analysis Engineer. 

 

This position reports to the Head of R&D Packaging & Failure Analysis. If you are from medical device industry with experience in any R&D function, this position would be suitable for you. 

 

Key responsibilities 

  • Lead or participate in CAPA and/or NCR in customer complaints and nonconformities in NPD and lifecycle products. 

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

  • Conduct investigation and determine the root cause of the nonconformity or potential nonconformity. 

  • Compose technical or problem-solving report and presentations to communicate findings and proposed solutions. 

  • Collaborate within RD, manufacturing, QA and other stakeholders to identify the appropriate solutions to correct problem and prevent recurrence.  

  • Develop new failure analysis method, best known method, processes and tools to improve the failure analysis process. 

  • Mentor and guide Junior Engineers in verification of failure analysis findings and develop their problem-solving skills. 

  • Undertake other duties as assigned to support the R&D objectives. 

 

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 2 to 3years of proven experience in failure analysis, 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. 

  • Knowledge in CAPA and NCR process 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.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

For more information, please visit ambu.com or follow us on LinkedIn.
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