Medical Devices Test Engineer

22 hours ago

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

OrganOx is seeking a skilled Medical Device 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:
  • Develop and implement test plans to ensure compliance with ISO 13485/FDA regulatory requirements and applicable test standards.
  • Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams to support design change and QMS documentation.
  • Conduct bench testing and verification activities, including supporting devices at external test houses, and conducting other bench tests where appropriate.
  • Assist in the assembly of prototypes and test fixtures for components.
  • Develop test protocols and document all activities within our Quality Management System.
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.
  • Ability to produce Technical Reports to a good standard both in terms of technical content, presentation and written English.
  • 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.
What We Offer:

As a Medical Device Test Engineer at OrganOx, you will have the opportunity to work in a dynamic and innovative environment, contributing to the development of cutting-edge medical devices. You will be part of a small, multi-disciplinary team of engineers, including electronics, mechanical and software development, and will have the chance to work on a wide range of projects, from planning and creating test strategies to conducting bench testing and verification activities.

We are looking for a highly skilled and motivated individual who is passionate about medical device testing and quality assurance. If you are a detail-oriented and organized individual with excellent communication skills, we encourage you to apply for this exciting opportunity.

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