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 Digital Test Specialist is responsible for defining, implementing, and continuously improving quality assurance and test strategies across OrganOx’s digital and data products. This includes regulated medical device software, cloud platforms, data pipelines, analytics, and internal/commercial digital products.
This role will act as the Test Authority within the Digital & Data team, working closely with Software Engineers, Data Scientists, Product Managers, Clinical Specialists, Regulatory, Quality and external partners. The post-holder will ensure that quality is built into delivery, from requirements through to release, operation and post-market support.
This is a hands-on strategic role, balancing test strategy, process definition and tooling, with direct contribution to validation, automation and risk management activities.
This is an on-site position in Oxford, with flexibility.
Major Responsibilities
QA Strategy & Leadership
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Define and own the QA and test strategy for Digital and Data products, across their full lifecycle.
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Establish pragmatic, risk-based testing approaches aligned with medical device regulations and OrganOx delivery practices.
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Act as a quality advocate within the Digital team, promoting testability, automation and early validation.
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Mentor and support Engineers and Analysts in quality best practices, including test design and defect management.
Testing & Validation
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Lead verification and validation activities for regulated digital products, ensuring compliance with IEC 62304, ISO 14971, and applicable FDA requirements.
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Define and maintain test plans, test cases, test protocols and traceability to requirements and risks.
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Oversee system, integration, end-to-end and regression testing across software, data pipelines, and integrations.
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Perform and coordinate hands-on testing where appropriate, particularly for high-risk changes.
Automation & Tooling
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Define and evolve test automation strategies for Digital products, APIs, data pipelines, and cloud platforms.
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Select, implement, and maintain appropriate test tools and frameworks.
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Ensure automated tests are integrated into CI/CD pipelines, where applicable.
Data & Platform Quality
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Establish quality controls for data ingestion, transformation, analytics and reporting pipelines.
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Define validation approaches for data accuracy, completeness, consistency and lineage.
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Support Quality Assurance for cloud-based platforms, integrations and connected systems.
Risk, Compliance & Documentation
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Lead software and data risk analysis activities, in accordance with ISO 14971.
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Ensure test evidence and quality records are suitable for audits, regulatory submissions and internal reviews.
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Contribute and influence SOPs, work instructions and continuous improvement of OrganOx quality processes.
Collaboration & Stakeholder Engagement
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Develop and maintain close partnerships across Digital, Data Science, Regulatory, Clinical and Operations teams.
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Proactively support internal and external audits and inspections.
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Lead the coordination of QA activities with external development and testing partners, where applicable.
Requirements
Skills & Experience
Essential:
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Strong experience in software QA / test leadership roles, ideally within regulated or safety-critical environments.
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Solid understanding of verification and validation principles for medical device software.
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Proven experience of designing and executing risk-based test strategies.
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Hands-on experience with both manual and automated testing approaches.
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Solid and proven familiarity with cloud-based systems, APIs, and data-driven architectures.
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Strong working knowledge of defect management, change control, and traceability.
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Excellent analytical, documentation and communication skills.
Desirable:
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Proven track record of working with data platforms, analytics, or data science workflows.
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Exposure and competent understanding of to CI/CD pipelines and modern DevOps practices.
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Established knowledge of cybersecurity testing principles (e.g. IEC 81001-5-1).
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Demonstrable experience of working effectively with external software delivery partners.
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Standards & Regulatory Knowledge
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IEC 62304 – Medical device software lifecycle processes.
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ISO 14971 – Application of risk management to medical devices.
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FDA regulations for Class II/III medical devices.
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Understanding of validation in both Agile and Waterfall delivery models.
Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, or a related discipline (or equivalent experience).
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Experience in the medical device industry is strongly preferred
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Excellent problem-solving skills and the ability to troubleshoot complex issues.
Strong communication and interpersonal skills that reflect our values of teamwork and respect.
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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.
