Software Quality Engineer

Organ Ox 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. Organ Ox 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. 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 Software Quality Engineer will work closely with R&D, Engineering, Post‑Market Operations and Quality teams to ensure effective control of design, development, risk assessment, and change control.

They will provide Quality and Design Assurance oversight across the software lifecycle for medical devices, including IEC 62304 software and digital health applications. The role works closely with Regulatory Affairs to ensure software documentation and procedures meet applicable standards and regulatory expectations

Building upon the company’s success in organ preservation for liver transplantation, several new applications of the technology are now being actively developed. The successful candidate will join a rapidly growing Quality department working with R&D, Post‑Market Engineering, Cybersecurity and Regulatory Affairs and play a key role in supporting compliance with EU MDR, FDA requirements and applicable software and cybersecurity standards, for new and existing products.

A central responsibility of the role is ensuring effective software risk management, particularly the development and maintenance of Software FMEAs (SFMEAs), software hazard analyses, cybersecurity risk assessments and associated risk controls

This is an onsite role in Oxford with flexibility.

Under direction from the Software Quality Manager, the Software Quality Engineer will:

• Assure software quality throughout the full lifecycle process in accordance with Organ Ox software standards and procedures for software up to safety class C per IEC 62304.
• Ensure effective implementation of software design controls, including requirements, architecture, verification and validation, configuration management, change control and release management.
• Ensure appropriate traceability between software hazards, failure modes, software requirements, risk‑control measures and verification evidence.
• EnsuresoftwareFMEAs are aligned with system‑level risk analyses, including system FMEAs, use‑related risk analyses and the overall ISO 14971 risk‑management file.
• Review software lifecycle documentation for completeness, consistency, traceability and regulatory compliance.
• Participate in design reviews, risk reviews, change assessments, project milestones and release‑readiness reviews.
• Provide Quality oversight of cybersecurity risk management, including threat modelling, vulnerability assessment, SOUP and third‑party software.
• Maintain and improve software procedures in line with IEC 62304, ISO 13485, ISO 14971, EU MDR, applicable FDA requirements and cybersecurity guidance.
• Supporting Quality oversight of computer system validation/assurance (CSV)/CSA.
• Ensure software defects,…