Job Description

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

The Test Technician will be executing the system test activities involving electrical/electronic, mechanical, material, software and medical system in the areas of function, performance, safety, interface and reliability. Maintaining the proper documentation for traceability. Embracing a culture of innovation, technical excellence, growth mindset and delivery responsibility; enabling efficient development of cutting-edge Class 3 Medical Devices in an ISO 13485, 21 CFR PART 820 and MDR quality management system environment.

This is an onsite role based in Oxford, working with a team of employees also based at Oxford and additional external resources where required by the project.

Listed below are the key responsibilities of the role and a high-level description of key tasks to be performed.

Major Responsibilities

Under direction from Systems Test Engineering Manager, the Test Technician will be responsible for:

• Executing system test of activities across the product and project portfolio to ensure the test plan and test procedure are followed.
• Assisting unit testing, integration testing and ad hoc testing activities.
• Providing feedback for the test procedure, work instruction for continuous improvement.
• Documenting test results accurately and timely, compiling objective evidence, and generating reports in DHF, DMR, and DHR, ensuring compliance with QMS and applicable international standards.
• Entering test data to test and issue management systems.
• Building test fixtures, maintaining equipment, tools and assets for testing, including calibration and inventory records.
• Keeping records of sample and prototype inventory.
• Working with external resources such as accredited laboratories.
• Providing recommendations for process, tools and test methods improvement.
• Supporting formulation of user and product requirement specifications to ensure the specification items are testable.
• Adhering to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Requirements

Skills & Experience

• Hands-on experience in executing test procedures for the mechatronic system.
• Strong understanding and/or experience with mechanical/electronics testing, software driven mechatronic devices, precision control, fluid flow control and/or hydraulics
• Able to read and interpret schematics, wiring diagrams, process flow diagrams, and technical documentation.
• Proven experience in infrastructure and tool qualifications.
• Excellent documentation skills and experience in common test and issue management systems (e.g. Azure DevOps, JIRA, GitHub etc)
• Basic knowledge of medical device standards and regulatory requirements.
• Strong attention to detail and ability to follow test procedures and protocols.
• Willing to collaborate with stakeholders, provide timely feedback, and progress updates.
• Proficiency in using test equipment in the field of electronics, electrical, and mechanical.
• Experience with test automation tools or scripting is desirable.

Qualifications

• Associate or Bachelor’s in Engineering, Biomedical Sciences or a related field.
• A well established and proven track record in systems testing within the medical device industry is desirable.
• Ability to travel 10%

Benefits

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 all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.