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

Skills & Experience

• Proven experience in software testing for complex, safety-critical systems, with a strong track record in the release and maintenance of Class II/III medical devices or similar regulated products.
• Solid understanding and practical application of software testing methodologies, including unit, integration, system, and Verification & Validation (V&V).
• Experience with test automation frameworks and tools, including scripting (e.g. Python or similar languages).
• Experience developing and maintaining Continuous Integration / Continuous Deployment (CI/CD) pipelines and working with version control systems (e.g. Git, Bitbucket).
• Strong capability in debugging, static analysis, vulnerability assessment, and intellectual property protection practices.
• Working knowledge of cybersecurity principles, including exposure to cybersecurity testing in regulated environments.
• Strong understanding of Software Development Life Cycle (SDLC) and risk management standards relevant to medical devices (e.g. IEC 62304, ISO 14971, ISO 13485, FDA software validation and cybersecurity guidance).
• Good understanding of design controls, traceability, audit requirements, and Design History File (DHF) documentation aligned with QMS (Quality Management System) expectations.
• Ability to define and execute robust test strategies and test cases, ensuring full traceability and coverage of requirements.
• Familiarity with Agile/Scrum methodologies, including Test-Driven Development (TDD) and Behaviour-Driven Development (BDD).
• Continuous improvement mindset focused on enhancing test processes, automation, and quality systems.
• Proven ability to identify technical risks and implement effective mitigation strategies proactively.
• Experience managing internal and external stakeholders and technical partners across the full design lifecycle, from concept to delivery acceptance.
• Demonstrated ability to develop innovative solutions while maintaining and improving existing products in compliance with internal QMS and external standards.
• Strong track record of contributing to process improvements to enhance efficiency, compliance, and product quality.
• Active contributor to Agile project planning and delivery activities.
• Strong focus on traceability, repeatability and compliance, without compromising engineering quality.
• Proven ability and expertise using tools for requirements management (e.g. Code Beamer, Jama, Polarion), task management (e.g. Jira, Azure DevOps) and Unified Modelling Language (UML) e.g. Enterprise Architect.

 

Soft Skills:

• Demonstrates strong problem-solving capability using structured techniques (e.g. brainstorming, 5 Whys, fishbone) to define activities and deliver tangible outcomes with minimal supervision.
• Effective and proactive communicator who engages stakeholders in a timely manner.
• Proven ability to collaborate effectively within cross-functional teams.
• Highly competent in documentation and reporting.
• Strong root cause analysis and defect investigation skills, with a high level of attention to detail.

 

Qualifications

• Degree in Computer Science or relevant engineering discipline

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.