DevOps Engineer/Senior

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 DevOps Engineer/Senior is responsible for the design, implementation and management of the ISO 62304 compliant CI/CD pipeline for the software development at OrganOx.

The DevOps Engineer/Senior will be actively involved in the entire Software Development Life Cycle (SDLC), focusing on automation of standardised development activities (e.g. static analysis, SBOM creation, v

ulnerability tests), management of version control system, including branching strategies and release process, as well as owning the software toolchain configuration, upkeep and continuous improvement.

The DevOps Engineer/Senior will collaborate closely with cross-functional teams, including Digital, Data Science/ML Engineers, Systems Engineers, QARA team, Operations and Field Service teams, to support the development of software for medical devices, whilst also supporting Design Transfer and software releases. 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, to ensure the creation and release of world-class software for OrganOx.

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 DevOps Engineer will be responsible for:

CI/CD automation

:

• Design, implement, and maintain CI/CD pipelines for build, test, and deployment ensuring compliance with industry standards such as IEC 62304, IEC 13485 and FDA regulations, critically including cybersecurity requirements
• Automating build, packaging and release processes to produce repeatable and traceable artefacts
• Integration of automated testing (unit, integration, system) into pipelines
• Managing environment promotion, approval gates and release controls
  
  
  

Source Control and Build Management:

• Enforcing branching strategies, pull requests and peer review
• Build orchestration and dependency management
• Creating reproducible builds and artefact versioning
• Managing build agents and runners
  
  
  

Infrastructure and Platform Engineering:

• Provisioning and maintaining cloud, onprem or hybrid environments
• Containerisation and orchestration (e.g. Docker, Kubernetes)
• Managing runtime environments for development, test, and production
• Monitoring infrastructure health, performance, and availability
• Proactively seek out opportunities to improve infrastructure reliability availability, and recovery with root cause analysis, failure investigations, by implementing defect remediation and new functionalities

Supporting incident response, root cause analysis, and remediation

Performance monitoring and capacity planning

Quality, Compliance & Traceability (where applicable)

• Supporting traceability from requirements to code, build, and deployment
• Ensuring build and release processes are auditable and reproducible
• Tool qualification and controlled change management in regulated environments
• Supporting evidence generation for audits and review
  
  
  

Process Improvement:

• Actively contribute to Lean/Agile initiatives, including but not limited to optimisation of QMS (Quality Management System) processes.
• Remain current and up to date with development in the software engineering domain
  
  
  

Collaboration & Troubleshooting:

• Work in close partnership with cross-functional teams, to diagnose and resolve issues efficiently
• Enable developer productivity through self-service tooling
• Support Agile and iterative delivery models
• Create clear documentation of pipelines, infrastructure and operational processes

An effective communicator, who readily engages in a timely and proactive manner

Proven ability to collaborate in cross-functional teams

Demonstrates appropriate & considered diligence when handling sensitive access to production systems, regulatory artefacts, and device infrastructure

Technical Expertise:

• Pipeline-as-code, using YAML or equivalent
• Strong experience with distributed version control systems (e.g. Git); branching strategies and protected branch policies
• Experience with major cloud platforms (Azure preferred, AWS/GCP acceptable)
• Identity and access management (IAM), secrets, and key management
• Deep appreciation of agile methodologies, best practices, and proactive contribution to project planning
• Proven ability to produce DHF-compliant documentation to a high standard, aligned with QMS (Quality Management System) requirements
• Strong focus on traceability, repeatability, and compliance without compromising engineering quality
• Scripting languages: PowerShell, Python, Bash (for build automation, device provisioning, and deployment workflows)

Sufficient .NET and C/C++ knowledge to debug and diagnose build pipeline failures across managed and native codebases

Familiarity with embedded toolchains and cross-compilation environments

Infrastructure-as-code (e.g. Terraform, Pulumi, Bicep).

Development Approach:

• A deep appreciation of agile methodologies, their implementation and best practices in software development.
• 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
  
  
  

Qualifications

• Degree in Computer Science or relevant engineering discipline
  
  
  

Tools & Practices: Proven ability and expertise in -

• CI/CD: Azure DevOps (preferred)
• Version control: Git, Bitbucket, SVN
• Test frameworks: xUnit, NUnit, MSTest, VectorCAST
• Requirements management: Codebeamer, Jama, Polarion
• Work item management: Jira, Azure Boards
• Static analysis and SBOM generation in a regulated context advantageous
  
  
  

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.