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Medical Devices Test Engineer

2 months ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time
Job Description

OrganOx is seeking a highly 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 executing test strategies, verifying design changes, and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Test Planning and Execution: Develop and execute 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 field-based customer service, operations, and quality teams.
  • 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:
  • Strong Background: A strong background in a relevant science or engineering discipline is required.
  • Communication Skills: Excellent written and verbal communication skills are necessary to document activities in line with the ISO13485 Quality Management System and plan and report work to a standard suitable for review by regulatory authorities.
  • Technical Skills: Practical experience in verification of medical devices within an ISO13485/21CFR regulated environment, experience in writing test protocols aligned with Product Requirement Specifications, and experience in medical device development and design change control are essential.
  • Collaboration: The ability to collaborate effectively in a multi-disciplinary team and work within a small, dynamic team of engineers is crucial.
What We Offer:

OrganOx is a dynamic and innovative company committed to developing products that save lives. We offer a collaborative and supportive work environment, opportunities for growth and development, and a competitive compensation package.