Windows Software Engineer/Senior - Safety Critical Systems position at OrganOx.| United Kingdom

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OrganOx Windows Software Engineer/Senior - Safety Critical Systems

Experience: General

Pattern: Full-time

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Oxford....United Kingdom

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 fulfill 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 Engineer is responsible for the design and development of the software at OrganOx. The Windows Software Engineer will be actively involved in the entire Software Development Life Cycle (SDLC), focusing on applications that deliver specific device functionalities, including product connectivity and robust cybersecurity measures, as well as supporting internal tools. The Windows Software Engineer will collaborate closely with cross-functional teams, including Electronics Engineers, Data Science/ML Engineers, Systems Engineers, QARA team, Operations and Field Service teams, to develop safe and reliable medical devices, whilst also supporting Design Transfer and Maintenance. These activities encompass Product Engineering, New Product Development and Innovation initiatives, carried out in collaboration with both internal teams and external stakeholders. This is an on-site role in Oxford with flexibility. The role is available at either Engineer or Senior Engineer level depending on experience. 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 of Embedded Software Development, the Windows Software Engineer/Senior will be responsible for: Software Development : Design and develop software for medical devices, while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485 and FDA regulations, critically including cybersecurity requirements. Implementation & Compliance : Develop robust software solutions and support cross-functional development activities, ensuring adherence to all phases of design control. This includes, but is not limited to: Responsible for requirements definition Responsible for mastery and ownership of design documentation Accountable for ensuring comprehensive traceability Proactively contributing to HA (Hazard Analysis), Usability and creation of FMEA (Failure Mode Effects Analysis) as part of risk analysis Responsible for code implementation Responsible and accountable for the delivery of rigorous and detailed code reviews Responsible and accountable for unit and integration testing Highly effective in working with the established toolchain CI/CD (Continuous Integration/Continuous Deployment) and continuously contribute meaningfully to its improvements. Software Maintenance : Proactively maintain and update software for safety-critical systems, contributing to the impact assessment, documentation and implementation of the requested changes Contribute to complaint resolution, including but not limited to root cause analysis, impact assessment and change management Proactively seek out opportunities to improve product reliability with root cause analysis, failure investigations, by implementing defect remediation and new features. Innovation : Proactively collaborate with other teams to collect inputs, develop prototypes and document the related activities during feasibility for new products or functionalities. Remain current with development in the software engineering domain. Process Improvement : Actively contribute to Lean/Agile initiatives, including but not limited to optimisation of QMS (Quality Management System) processes. Collaboration & Troubleshooting: Work in close partnership with cross-functional teams, to diagnose and resolve issues efficiently Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. Skills & Experience Focused and proven experience in software development, particularly for complex and safety-critical systems, with a strong demonstrable track record of releasing and maintaining class II / III medical devices or similar systems Comprehensive technical knowledge of standards and guidelines for developing safety-critical systems, with the ability to tailor compliance approaches to specific applications, maintaining strong focus on risk management, cybersecurity, scalability, maintainability, and reliability Proven track record of delivering high quality software in regulated industries, preferably in medical device development Proven experience developing device-hosted applications and services running on windows-based platforms Demonstrable track record of working with relational databases and proven track record on Windows security hardening Proven experience in managing external technical partners , ensuring the quality of deliverables across all aspects of design control within regulated industries Demonstrable proactivity in identifying technical risks and implementing effective mitigation strategies Skilled in developing innovative solutions and maintaining existing products while ensuring adherence to internal QMS and relevant industry standards Demonstrated track record of supporting process improvements to enhance efficiency and compliance Programming Skills : Expert in C# and modern .NET (.NET 6/7/8) in long lived production systems, PowerShell scripting and able to deliver code compliant with relevant coding standard 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 Proven ability to collaborate in cross-functional teams Development Approach : A deep appreciation of agile methodologies, their implementation and best practices in software development Proven track record applying Object Oriented methodologies for reuse and scalability, using design patterns and UML (Unified Modelling Language) concepts Proactive participation and contribution to project planning activities in the Agile context Proven ability to produce documentation for the DHF (Design History File) with high quality standard and compliant with QMS requirements and related standards Strong demonstrable experience of managing internal and external stakeholders from initial engagement (i.e. design input) throughout the design and development phases, to acceptance of deliverables Strong focus on traceability, repeatability and compliance, without sacrificing or compromising on engineering quality Technical Expertise : Advanced knowledge implementing multi-threading, asynchronous programming and deterministic behaviour in device environments Proven experience implementing dependency injection, configuration, and application lifecycle management using e.g. Microsoft.Extensions Strong working knowledge and application of messaging technologies (e.g. Azure IoT Hub, MQTT, AMQP) Strong understanding of TLS, certificate-based authentication and secure key handling Understanding of edge-to-cloud architectures. Proven experience designing OTA update mechanisms, including safe update strategies (e.g. rollback, validation, compatibility) Track record of implementing structured logging (e.g. using Serilog, NLog) Strong familiarity/ knowledge of telemetry concepts Strong foundation in cybersecurity best practices Qualifications Degree in Computer Science or relevant engineering discipline Tools & Practices : Proven ability and expertise in - Version control systems (e.g. Git, Bitbucket) Debugging tools CI/CD pipelines (e.g. for .NET, YAML) Unit Test tools (e.g. xUnit, NUnit or MSTest) Test-Driven Development (TDD) Behaviour-Driven Development (BDD) Requirements management tools (e.g. Code Beamer, Jama, Polarion) Task management (e.g. Jira) UML tools (e.g. Enterprise Architect

Windows Software Engineer/Senior - Safety Critical Systems job opportunity at OrganOx.

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