Safety Risk Management Specialist

vor 2 Wochen


Böblingen, Baden-Württemberg, Deutschland Bertrandt Vollzeit

Job Title: R&D Safety Risk Engineer for Hospital Patient Monitoring Device

About the Role:

  • As a key member of the R&D Safety Risk Engineering organization, you will be responsible for ensuring the safety and efficacy of our hospital patient monitoring device.
  • You will collaborate closely with system engineers and subject matter experts throughout the development process to identify and mitigate potential risks.

Key Responsibilities:

  • Develop and implement risk management strategies to ensure compliance with regulatory requirements, including ISO14971, FDA regulations 21CFR 820, EU MDR, IEC 62304, and IEC.
  • Conduct risk analysis using methodologies such as FMEA, FTA, and PHA to identify potential hazards and develop mitigation plans.
  • Collaborate with cross-functional teams to develop and implement safety protocols and procedures.
  • Provide expertise and guidance on risk management and safety engineering principles to ensure the development of safe and effective medical devices.

Requirements:

  • Completed degree in a relevant field such as system engineering, mechanical/electrical engineering, software development, computer science, or similar.
  • Minimum 5 years of experience in developing medical products and safety risk management for active medical devices, preferably for embedded systems.
  • Fluency in German and English.

What We Offer:

  • A challenging and dynamic work environment with opportunities for growth and development.
  • Collaborative and team-oriented approach with a focus on innovation and excellence.
  • Comprehensive training and support to ensure your success in the role.


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