R&D Failure Analysis Engineer
1 week ago
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 the 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 reports and presentations to communicate findings and proposed solutions.
- Collaborate within R&D, manufacturing, QA, and other stakeholders to identify the appropriate solutions to correct problems and prevent recurrence.
- Develop new failure analysis methods, best known methods, 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
- Bachelor's degree in Mechanical, Chemical, or Material Science or any equivalent engineering field.
- Minimum 2 to 3 years of proven experience in failure analysis, preferably in a manufacturing or product development environment.
- Good problem-solving skills and analytical skills with the ability to identify the root cause of failures.
- Good knowledge of problem-solving root cause analysis tools (e.g. fishbone diagram, 5 whys analysis).
- Good knowledge of statistical analysis using Minitab software.
- Good knowledge of using failure analysis equipment, such as SEM/EDX, FTIR, and other relevant analytical equipment is an added advantage.
- Knowledge of CAPA and NCR processes is an added advantage.
- Some years of experience in the medical device industry.
- Ability to work independently with minimum supervision, structured and systematic.
- Excellent written and oral communication skills, with the ability to create and deliver presentations to both technical and non-technical audiences.
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.
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