Senior Systems Test Engineer

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. 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.

Position Summary: The Senior Systems Test Engineer will be leading technical and project execution for the system test activities (verification and validation) involving electrical/electronic, mechanical, material, software and medical system in the areas of function, performance, safety, interface and reliability. Preparing the appropriate test plans, test procedures and executing system tests. 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 in Oxford, with flexibility, working with a team of employees also based at Oxford and additional external resources where required by the project.

Major Responsibilities: Under direction from Systems Test Engineering Manager, the Senior Systems Test Engineer will be responsible for:

• System test of designs across the product and project portfolio to ensure criteria are met across a range of attributes including function, performance, safety, interface and reliability.
• Preparing the test plan, test procedure and executing the in-house testing activities.
• Leading and monitoring the system testing activities with external resources such as accredited laboratories.
• 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.
• Providing guidance to Systems Test Engineers and Test Technicians.
• Supporting the development and qualification of tools and test methods, equipment or systems used in medical domain.
• Performing industry research on test methodologies and providing recommendations for process or tools improvement.
• Participating in formulation of user and product requirement specifications to ensure the specification items are testable.
• Assisting the maintenance and calibration of the equipment and assets.
• Collaborating with development team during concept and development phases to expedite product development, unit testing and integration testing.
• Providing input for Risk Management File, project plans, test strategies.
• Review of requirements, risks, design and trace for testability and impact to DV DHF.
• Adhering to the letter and spirit of OrganOx's Code of Conduct and all other company policies.

Requirements: Skills & Experience

• Familiar with test strategies and infrastructure development process.
• 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/electronics testing, software driven mechatronic devices, precision control, fluid flow control and/or hydraulics (not necessary to meet all).
• Willing to collaborate with stakeholders, provide timely feedback and progress update.
• Excellent report writing and documentation skills with quality mindset.
• Good 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 the unique challenges in related fields 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. A well established and proven track record in systems testing within the medical device industry, preferably with Class 3 devices (Desirable).

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.