Medical Device Test Engineer

2 weeks ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time
About OrganOx

OrganOx is a pioneering medical device company that has been revolutionizing organ transplantation since 2008. Our flagship product, the OrganOx metra, utilizes cutting-edge normothermic machine perfusion technology to preserve donor livers for up to 24 hours, reducing organ discard rates and enhancing transplantation success. As a fast-paced, innovative global company, we are committed to improving transplantation outcomes.

Job Summary

We are seeking a highly motivated Medical Device Test Engineer to join our Product Engineering team. This role will be responsible for planning and executing test strategies, verifying design changes, and collaborating with cross-functional teams to ensure compliance with regulatory requirements.

Key Responsibilities
  • Test Planning and Execution: Develop and implement test plans to support verification activities and design change submissions.
  • Design Change Verification: Verify design changes and new features to ensure compliance with regulatory requirements.
  • Root Cause Analysis: Assist in root cause analyses of field performance issues, working closely with customer service, operations, and quality teams.
  • Test Equipment Maintenance: Ensure test and laboratory equipment is well-maintained and calibrated in accordance with QMS requirements.
  • Test Rig Development: Develop test rigs and fixtures, and procure test equipment as needed.
Requirements
  • Education: A degree in Science or Engineering or equivalent relevant experience.
  • Experience: Practical experience in verification of medical devices within an ISO13485/21CFR regulated environment.
  • Skills: Strong background in the development and execution of verification and validation protocols, with excellent written and verbal communication skills.
What We Offer

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development. We are an equal opportunity employer and welcome applications from diverse candidates.



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