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 fulfill 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.
Position Summary
The 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 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 based in Oxford, with flexibility, 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. This list is not exhaustive.
Major Responsibilities
Under direction from Systems Test Engineering Manager, the 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 procedure, work instruction and executing the in-house testing activities.
* Coordinating 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 Test Technicians.
* Supporting the development and qualification of tools and test methods, equipment or systems used in medical domain.
* 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.
* 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
* Hands-on experience in creating test methodologies and test procedures for the medical system.
* Hands-on experience working with external test houses to ensure compliance with relevant international standards.
* Experience with mechanical/electronics testing, software driven mechatronic devices, precision control, fluid flow control and/or hydraulics (not necessary to meet all).
* Proven experience in infrastructure and tool qualifications.
* 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 this field are 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.