Medical Devices Test Engineer

1 month ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time
Medical Devices Test Engineer

OrganOx is seeking a skilled Medical Devices Test Engineer to join our Product Engineering team. As a key member of our team, you will be responsible for planning and creating test strategies and test plans to support verification activities and design change submissions.

Key Responsibilities:

  • Assist in root cause analyses of field performance issues, working closely with field-based customer service, operations, and quality teams.
  • Support the wider team in ensuring compliant design and verifying performance.
  • Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams to support design change and QMS documentation.
  • Develop test protocols and document all activities within our Quality Management System.
  • Produce Technical Reports to a good standard, both in terms of technical content and written English.

Requirements:

  • Strong background in relevant science or engineering discipline.
  • Excellent written and verbal communication skills to document activities in line with the ISO13485 Quality Management System.
  • Practical experience in verification of medical devices within an ISO13485/21CFR regulated environment.
  • Experience in writing test protocols aligned with Product Requirement Specifications.
  • Experience in medical device development and design change control.
  • Hands-on experience of build and test of electro-mechanical devices.

About OrganOx:

OrganOx is a dynamic and innovative medical device company, striving to achieve excellence in the field of organ transplantation. We are committed to delivering high-quality products and services that meet the needs of our customers and patients.



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