Senior R&D Engineer

5 days ago


Bayan Lepas, Penang, Malaysia B. Braun Melsungen AG Full time

We are seeking a highly skilled Senior R&D Engineer - Risk Management to join our team at B. Braun Melsungen AG. In this role, you will be responsible for evaluating and monitoring development procedures, SOPs, documentation, and records to ensure compliance with daily practices.

You will also implement risk management and product risk analysis, focusing on usability engineering and human factors engineering. This is a critical role that requires strong analytical and problem-solving skills.

  • Demonstrate expertise in methodological compliance for Risk & Usability Methods within Medical Device Development & Lifecycle-Management.
  • Stay up-to-date with industry regulations and standards, including ISO 14971:2019, IEC 62366-1:2020, and FDA Guideline for Human Factors 2016.

Requirements:

  • Bachelor of Science and Engineering. At least 2 years of experience in a related field or in Quality Engineering/Management within the medical device industry.
  • Excellent written and communication skills.

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