Embedded Software Engineer​/Senior - Safety Critical Systems

ABOUT ORGANOX:

Organ Ox 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. Organ Ox 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.

The Embedded Software Engineer is responsible for the design and development of the software at Organ Ox.

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.

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…