Senior Systems Engineer

3 days ago


Eastleigh, Hampshire, United Kingdom Amber Therapeutics Full time

About the Role

We are seeking a seasoned systems engineer to lead our medical device risk management efforts as a Senior / Principal Systems & Risk Engineer. This critical role will drive the integration of risk management into the design and development of active implantable medical devices, ensuring the safety, efficacy, and compliance of our products.

Key Responsibilities:

  • Leverage your expertise in risk analysis tools and techniques to identify, assess, and mitigate risks associated with our medical devices.
  • Develop and maintain a comprehensive requirements management system to ensure alignment with technical, clinical, and regulatory objectives.
  • Serve as the subject matter expert during audits related to risk management and traceability, providing mentorship and guidance to junior engineers as needed.

Requirements:

  • Bachelor's degree in Engineering, Biomedical or Systems Engineering, or a related field.
  • Proven experience in medical device risk management, with a focus on active implantable medical devices preferred.
  • Deep understanding of ISO 14971 and its application to medical device development is essential.

The estimated salary for this role is £80,000 - £110,000 per annum, depending on experience.



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