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). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia and has been utilized in over 7,000 liver transplants to date, enabling longer preservation times and functional assessment of the organ prior to transplant, increasing the number of organs available for transplantation. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Position Summary
The Senior Systems Test Engineer will lead technical and project execution for system test activities (verification and validation) involving electrical/electronic, mechanical, material, software, and medical system components across function, performance, safety, interface, and reliability. Responsibilities include preparing test plans and procedures, executing system tests, and fostering a culture of innovation, technical excellence, and delivery responsibility in an ISO 13485, 21 CFR PART 820, and MDR quality management environment. The role is onsite in Oxford with flexibility and collaboration with internal and external resources.
Major Responsibilities
* System test of designs across the product and project portfolio to ensure criteria are met across function, performance, safety, interface, and reliability attributes.
* Preparation of test plans, procedures, and execution of in‑house testing activities.
* Leadership and monitoring of system testing activities with external resources such as accredited laboratories.
* Documentation of test results accurately and timely, compiling objective evidence, and generating reports in DHF, DMR, and DHR, ensuring compliance with QMS and applicable international standards.
* Provision of guidance to Systems Test Engineers and Test Technicians.
* Support for the development and qualification of tools and test methods, equipment, or systems used in the medical domain.
* Industry research on test methodologies and recommendations for process or tool improvement.
* Participation in formulation of user and product requirement specifications to ensure testability.
* Assistance with maintenance and calibration of equipment and assets.
* Collaboration with the development team during concept and development phases to expedite product development, unit testing, and integration testing.
* Input for Risk Management File, project plans, and test strategies.
* Review of requirements, risks, design, and trace for testability and impact to DV DHF.
* Adherence to the letter and spirit of OrganOx's Code of Conduct and all other company policies.
Skills & Experience
* Familiarity with test strategies and infrastructure development processes.
* Hands‑on experience in tool qualifications, designing test fixtures, creating test methodologies, and test procedures for the medical system independently.
* Hands‑on experience working with external test houses to ensure compliance with relevant international standards.
* Knowledge of data analysis, sampling theory, and statistical methods.
* Experience with mechanical/electronic testing, software‑driven mechatronic devices, precision control, fluid flow control, and/or hydraulics (not all required).
* Willingness to collaborate with stakeholders, providing timely feedback and progress updates.
* Excellent report‑writing and documentation skills with a quality mindset.
* Strong project‑management skills and the ability to manage multiple priorities in a fast‑paced environment.
* Experience with Class 2 or 3 medical devices and familiarity with related challenges are highly desirable.
* Demonstrable knowledge of the regulatory environment, including FDA, IEC 60601, ISO 13485, ISO 62366, ISO 14971, and other relevant standards.
* Experience with test automation tools or scripting (e.g., Python).
Qualifications
* Bachelor's or Master's degree in Engineering, Biomedical Sciences, or a related field.
* Well‑established track record in systems testing within the medical device industry, preferably with Class 3 devices (desirable).
Benefits
OrganOx values innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. Work‑life balance is supported, and opportunities for ongoing professional development are provided.
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.
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