Senior Design Assurance 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). 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.

Position Summary

The Senior Design Assurance Engineer is responsible for ensuring that OrganOx products meet the highest standards of safety and regulatory compliance through robust, lifecycle-long risk management activities. This role focuses on maintaining and improving the risk management process in accordance with ISO 14971, supporting design teams in identifying, evaluating, and controlling risks, and ensuring that risk documentation is complete, consistent, and audit-ready.

The successful candidate will join a rapidly growing Quality department and play a key role in shaping the risk management approach for both new and existing products.

This is a flexible, on‑site role in our Oxford facility, working closely with R&D, Engineering, Post‑Market Operations and Quality teams to ensure effective control of design, development, risk assessment, and change control.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Design Assurance Manager, the Senior Design Assurance Engineer (Risk Management) will:

• Lead and maintain risk management activities throughout the full product lifecycle in accordance with ISO 14971 and OrganOx procedures for Class II & III medical devices.
• Develop, update, and maintain risk management files, including hazard analyses, FMEAs, fault trees, benefit–risk assessments, and risk traceability.
• Facilitate and document risk reviews for new and existing devices, ensuring cross‑functional input and alignment with regulatory expectations.
• Support verification and validation activities by ensuring risk‑driven test coverage, reviewing protocols and reports, and confirming that risk controls are adequately verified.
• Monitor post‑market data (complaints, field performance, CAPA inputs) to ensure risks remain acceptable and design files remain current.
• Ensure compliance with global regulatory requirements by reviewing standards, supporting audits, and contributing to continuous improvement of the Quality process.
• Collaborate with design teams to ensure Design Assurance principles are adhered to throughout development, including verification planning and documentation quality.
• Contribute to other Design Assurance tasks as required to support the wider Quality function.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies