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 Windows Software Manager is responsible for leading the design and development of software at OrganOx, for device-hosted applications and services running on Windows-based platforms, ensuring delivery of robust, high-quality solutions for regulated medical environments. The role combines deep technical expertise developing Graphical User Interfaces (GUI), connectivity solutions and implementing cybersecurity mitigations, with strong leadership of teams, projects and cross-functional stakeholders.
Operating with a system-level perspective, the Windows Software Manager takes end-to-end ownership of the application 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 Windows Software Manager will be responsible for:
Resource management
- Lead and manage a team of Windows software engineers, fostering a high-performance culture of collaboration, continuous improvement, and engineering excellence.
- Providing line management, including goal setting, performance reviews, development planning, and ongoing coaching.
- Mentor and support engineers in low-level design, debugging, and real-time system development challenges.
- 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 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.
- Guide technical decisions, design reviews.
- Ensure robust software integration with cross-functional teams
- Drive Agile or hybrid Software Development Life Cycle (SDLC) practices.
- Author and execute a roadmap of developments to improve the Software Engineering function, with emphasis on application-level software.
- Financial forecasting and spend tracking against approved department and project budgets.
Technical Oversight & Execution
- Provide technical leadership for the development of application-level software for Class II and Class III medical devices.
- Oversee the full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance.
- Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards.
- Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design best practices.
- Contribute hands-on expertise in complex or critical technical areas when required.
- Drive design principles that support modularity, testability, maintainability, scalability.
- Oversee release quality, defect management, and continuous improvement initiatives.
Process and tools
- SOPs (Standard Operating Procedures) and Work Instructions supporting Software Engineering.
- Selection, development, and qualification of Software Engineering tools and systems.
Continuous Improvement & Innovation
- Stay current with industry trends, emerging technologies, and best practices in software 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
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).
- Proven understanding of edge-to-cloud architectures.
- Solid experience designing OTA update mechanisms, including safe update strategies (e.g. rollback, validation, compatibility)
- Strong working knowledge and application of messaging technologies (e.g. Azure IoT Hub, MQTT, AMQP).
- Solid expertise in C#, C++ and .net framework.
- Familiar with Real-Time Operating System (RTOS) concepts (task scheduling, interrupts, concurrency) and Board Support Package (BSP).
- 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.
- Strong systems-thinking capability, with the ability to view and optimise across 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.
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.