Software 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). 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 Software Test Engineer is a regulatory-critical, safety-focused engineering role responsible for supporting the full software lifecycle at OrganOx—from requirements definition through to post-market activities. The role ensures patient safety through rigorous testing, while maintaining full compliance and end-to-end traceability.

The Software Test Engineer works closely with cross-functional teams, including Electronics, Data Science/ML, Systems Engineering, Quality Assurance Regulatory Affair (QARA), Operations, and Field Service, to review design inputs, define, execute, and document software testing, and manage the configuration of software artefacts. This includes both released products and supporting tools. These responsibilities span Product Engineering, New Product Development, and Innovation initiatives, in collaboration with both internal teams and external partners.

This is an on-site role in Oxford with flexibility, to ensure the creation and release of world-class software for OrganOx.

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 Director, Embedded Software Development, the Software Test Engineer will be responsible for:

Test Planning & Strategy

• Contribute to the development of verification and validation (V&V) strategies aligned with IEC 62304 lifecycle requirements.
• Develop test plans, test cases, and protocols derived from system and software requirements.
• Ensure end-to-end traceability between requirements, risks, and test coverage.

Test Execution & Validation

• Execute integration, system, and regression testing throughout the product lifecycle.
• Perform both functional and non-functional testing (e.g. performance, usability, safety).
• Verify that software meets intended use, safety, and regulatory requirements.

Automation & Tooling

• Design, develop, and maintain automated test frameworks and Continuous Integration / Continuous Deployment (CI/CD) pipelines.
• Integrate testing into continuous integration environments to ensure repeatability and auditability.
• Validate tools used within the software development and testing lifecycle.

Defect Management & Root Cause Analysis

• Identify, log, track, and verify defects and anomalies.
• Perform root cause analysis and support Corrective And Preventive Actions (CAPA).

Compliance & Documentation

• Ensure compliance with IEC 62304, ISO 13485, ISO 14971, and relevant FDA regulations.
• Produce and maintain audit-ready documentation, including test reports and verification evidence.
• Maintain design control artefacts and traceability to support regulatory submissions.

Risk & Safety Testing

• Support hazard analysis, FMEA, and usability validation activities.
• Ensure testing reflects risk classification (Class A/B/C) and safety impact.

Collaboration & Cross-Functional Support

• Contribute to design reviews, requirements analysis, and technical troubleshooting across teams.

Post-Market & Maintenance Activities

• Support maintenance testing, impact analysis, and change validation.
• Contribute to complaint investigations and field issue resolution.

Innovation

• Collaborate across teams during feasibility activities to define and develop test approaches for new products and features.
• Stay current with advancements in software testing practices and technologies.

Process Improvement

• Contribute to Lean and Agile initiatives, including continuous improvement of Quality Management System (QMS) processes.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies