Embedded Software Engineer / Senior - Safety Critical Systems

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 Embedded Software Engineer is responsible for the design and development of the software at OrganOx.

The Embedded Software Engineer will be actively involved in the entire Software Development Life Cycle (SDLC), focusing on the Board Support Package (BSP), drivers and embedded software applications, including but not limited to, control loops and algorithms implementation, ensuring the optimal operation of hardware within the products and internal tools.

Working closely with cross-functional teams, including Electronics Engineers, Data Science/ML Engineers, Systems Engineers, QARA team, Operations and Field Service teams, the Embedded Software Engineer will 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 can be filled 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 Embedded Software Engineer 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

Requirements

Skills & Experience

• Focused and proven experience in Embedded Software development, particularly for complex or safety-critical systems, with a strong demonstrable track record of releasing and maintaining class II / III medical devices or similar systems
• Industry Background: Proven track record of delivering high quality software in regulated industries, preferably in medical device development
• 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 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/C++, scripting languages and able to deliver code compliance, within the required relevant coding 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
• 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 and acceptance of deliverables
• Strong focus on traceability, repeatability and compliance, without sacrificing or compromising on engineering quality

Technical Expertise: Advanced knowledge of the following-

• implementing multi-tasking systems using RTOS (i.e. SafeRTOS)
• developing for micro-controllers and micro-processors,
• implementing communication protocols (e.g. I2C, SPI, UART, USB, Ethernet, CAN)
• developing HAL (Hardware Abstraction Layer)
• creating solutions for IoT devices
• addressing cybersecurity risks

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 (e.g. IAR)
• CI/CD pipelines (e.g. Azure)
• 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)

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.