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 Manager is responsible for leading the testing of the software developed in OrganOx from planning to protocols definition and testing activities, including the software risk-analysis and verification reports, ensuring patient safety through rigorous testing, while maintaining full compliance and end-to-end traceability.
The role combines deep technical expertise in software testing with strong leadership of teams, projects, and cross-functional stakeholders. Operating with a system-level perspective, the Software Test Manager takes end-to-end ownership of the software testing including the implementation and maintenance of the Continuous Integration / Continuous Deployment (CI/CD) toolchain and post market surveillance activities involving software, driving alignment with quality standards and regulatory compliance requirements. The role also serves as a key technical representative for OrganOx, engaging confidently with external stakeholders including regulatory bodies, partners, and customers.
This is an on-site role in Oxford with flexibility.
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 Manager will be responsible for:
Resource management
- Lead and manage a team of Software Test Engineers, fostering a high-performance culture of collaboration, continuous improvement, and engineering excellence.
- Provide effective line management, including goal setting, performance reviews, development planning, and ongoing coaching.
- Mentor and support Engineers in testing activities challenges (i.e. protocol definitions, reports contents, non-regression testing, Failure Mode Effect Analysis (FMEA), Continuous Integration / Continuous Deployment (CI/CD) implementation).
- Define and maintain an effective team structure, including roles, responsibilities, operating mechanisms and supporting infrastructure.
- Plan and manage resource allocation, including headcount planning, role definition, workload distribution, and optimisation of team utilisation across distributed teams.
- Oversee and own recruitment activities, including identifying hiring needs, interviewing, candidate evaluation, hiring recommendations, onboarding, and probation management.
- Maintain visibility of team capabilities (knowledge, skills, and abilities) and develop targeted training and development plans to address gaps and enhance performance.
- Facilitate clear and effective communication within the team and across stakeholders, ensuring alignment with wider organisational objectives.
Planning
- Manage project timelines, resources, and budgets, ensuring projects are delivered on time and within scope.
- Effectively guide technical decisions, design reviews.
- Ensure robust software integration tests with cross-functional teams
- Drive Agile or hybrid Software Development Life Cycle (SDLC) practices in software testing contexts
- Author and execute a detailed roadmap of developments to improve the software testing.
- Financial forecasting and spend tracking against approved department and project budgets.
Technical Oversight & Execution
- Provide technical leadership for the implementation of testing strategy on software for Class II and Class III medical devices.
- Oversee the full software development lifecycle, including requirements definition, architecture, implementation, testing, risk, cybersecurity and maintenance.
- Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, ISO 14971 and other relevant safety standards.
- Establish and enforce high-quality software design control practices, including code reviews.
- Contribute hands-on expertise in complex or critical technical areas when required.
- Own the software configuration, including the Software Bill Of Material (SBOM), Software Of Unknown Provenance (SOUP) validation, tools qualification and maintenance, software releases.
- Oversee release quality, defect management, and continuous improvement initiatives.
- Drive the implementation of the Continuous Integration / Continuous Deployment (CI/CD) and its mapping to deliverables required by the Quality Management System (QMS).
Process and tools
- SOPs (Standard Operating Procedures) and Work Instructions supporting Software Engineering with emphasis on testing.
- Selection, development, and qualification of software testing tools and systems.
Continuous Improvement & Innovation
- Stay current with industry trends, emerging technologies, and best practices in software testing and medical device development.
- Continuously improve development processes, tools, and engineering practices.
- Drive innovation in IoMT-enabled medical devices, ensuring seamless integration with cloud and connected systems.
- Introduce automation, performance optimisation, and data-driven analytics.
- Oversee and approve Software Engineering Design History Files (DHF)
- Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
Requirements
Skills & Experience
- Proven track record in the development, release, and maintenance of Class II/III medical device software or similarly safety-critical systems.
- Deep understanding of the Software Development Life Cycle (SDLC), including agile methodologies and comprehensive testing strategies (unit, integration, hardware-in-the-loop).
- Solid expertise in implementing testing frameworks (i.e. Test-Driven Development (TDD) and Behaviour-Driven Development (BDD)) and automation for both embedded and application-level software, including connectivity
- Awareness of Real-Time Operating System (RTOS) concepts (task scheduling, interrupts, concurrency), as well as microcontrollers, System-on-Chips (SoCs), device drivers, Hardware Abstraction Layer (HAL) Board Support Package (BSP), and hardware–software interaction as well as Over The Air (OTA) updates.
- Familiarity with Unified Modelling Language (UML) and object-oriented design principles.
- Demonstrated ability to build, lead, and develop high-performing engineering teams with a collaborative leadership approach.
- Proven ability to use and integrate 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.
- Strong systems-thinking capability, with the ability to view and optimise across hardware, firmware, and software layers under real-world constraints.
- Proven problem-solving skills, including proactive identification and mitigation of technical risks.
- Experience with model-based and model-driven development, and simulation tools to accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration.
- Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366.
- Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability and reliability.
- Proven experience managing external technical partners and ensuring quality deliverables across the full product lifecycle.
- Track record of driving process improvements to enhance efficiency, compliance, and product quality.
- Skilled in both developing innovative solutions and maintaining existing products in line with QMS (Quality Management System) and industry standards.
- Highly effective in applying problem-solving techniques (e.g. brainstorming, 5-whys, fishbone), supported by demonstrable structured and rigorous approach to define activities and achieve tangible deliverables with limited supervision
- An effective communicator, who readily engages in a timely and proactive manner
- Passion for innovation and commitment to developing medical devices that improve patient outcomes.
Qualifications
- Bachelor’s or Master’s degree in Computer Science, Electrical Engineering, or a related field.
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.