Software Engineer, Quality & Process

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 Software Engineer, Quality & Process will utilise their extensive experience in Software Quality Assurance, particularly in cloud solutions used in medical applications and embedded medical device development. This role will play a critical role in ensuring our cloud platform and medical devices meet the stringent quality and regulatory standards required for medical devices.

This is a fantastic opportunity to join a fast-growing organisation in a strategic role that will have significant impact on the company’s digital offering and contribute to how organ transplants are delivered. While this position is in the Software Development team, the role works in partnership with the quality function.

This is an on-site position 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 Software Engineer, Quality & Process will be responsible for:

Quality Assurance & Testing:

• Development, implementation and maintenance of the Software Technical File for the products, defining the documental strategy and facilitating submissions.
• Act as primary interface between Software and Quality and Regulatory teams.
• Participate in the development and maintenance of software processes that meets all relevant Regulatory requirements, including but not limited to Standard Operating Procedures (SOPs) and Working Instructions (WI).
• Define and execute improvements activities, including but not limited to Corrective Actions Preventive Actions (CAPAs).
• Oversee the SOUP (Software of Unknown Provenance) and Tools validations securing compliance with internal QMS (Quality Management System).

Compliance & Documentation:

• Create all the software related documentation, including requirements, design, test reports and traceability, ensuring compliance and excellence in the rigour applied including derived outcome.
• Develop templates for software documentation and facilitate their integration with the software development toolchain, including the Continuous Integration/ Continuous Deployment (CI/CD) artifacts.
• Proactively manage partnerships, preparing and maintaining detailed documentation, including test plans, test cases, test scripts and test reports.

Risk and Cybersecurity Risk Management:

• Drive the software risk analysis activities, including the development and maintenance of the Failure Mode Effect Analysis (FMEA), identification of mitigations and their inclusion in the design input documentation.
• Drive the cybersecurity activities including threat modelling, penetration tests, identification, assessment and mitigation of software-related and cybersecurity risks, including those associated with the outsourced development and testing processes.
• Drive a key focus to develop and maintain a risk management plan in accordance with relevant standards and frameworks, ensuring all identified risks are documented and mitigated effectively.
• Take the lead to ensure regular and comprehensive review and update of software related risk through the software FMEA, to address any emerging risks during the software development lifecycle.

Collaboration & Communication:

• Role models effective stakeholder collaboration, working closely with software developers, product managers and other partners to understand requirements and design effective testing strategies.
• Ensures timely communication of findings, risks and recommendations, which are effective and clear to technical and non-technical stakeholders.
• Adhere to and role model the spirit of OrganOx’s Code of Conduct and all other company policies

Requirements

Skills & Experience

• Demonstrated experience in a similar role, preferably within the medical device industry.
• Proven experience in software quality assurance, with a focus on cloud solutions and software for Medical Devices (essential)
• Strong understanding of software development, testing methodologies, tools and processes (essential)
• Proven experience applying regulatory standards for Medical Devices (e.g., ISO 13485, FDA regulations, EN 62304, IEC 62366) (essential)
• Engineering experience in software risk management (ISO 14971), including cybersecurity risk management (essential)
• Excellent problem-solving skills and attention to detail (essential)
• Strong communication and collaboration skills (essential)
• Proven experience with cloud platforms such as AWS, Azure, or Google Cloud and IoMT solutions (desirable)
• Knowledge of medical device software lifecycle processes (essential)
• Familiarity in programming languages such as Python, Java, C# or C/C++ (desirable)
• Proven experience with continuous integration/continuous deployment (CI/CD) pipelines (desirable)
• Familiarity with relevant cybersecurity standards and frameworks (e.g., IEC 62443, NIST Cybersecurity Framework (essential)

Qualifications

• Bachelor’s degree in computer science, engineering, or a related field.
• Relevant certifications in software quality assurance or testing (e.g., ISTQB).

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.