Principal Software Engineer, Quality & Process

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Principal 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 - to 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.

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.

This is an on-site position in Oxford with flexibility.

Major Responsibilities

Under direction from the Director, Embedded Software Development, the Principal Software Engineer, Quality & Process will be responsible for:

Quality Assurance & Testing:

• Responsible and technical lead on the development, implementation and maintenance of comprehensive test plans and test cases for our Digital platform.
• Oversee and review testing output, including functional, regression, performance and security testing, ensuring excellence in the rigour applied and outcomes derived.

Compliance & Documentation:

• Drive the development of software processes that meets all relevant Regulatory requirements
• Proactively manages partnerships, preparing and maintaining detailed documentation, including test plans, test cases, test scripts and test reports.

Risk and Cybersecurity Risk Management:

• Lead the diligent 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 risk assessments, to address any emerging risks during the software development lifecycle.

Collaboration & Communication:

• Role models effective stakeholder management, 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

• Proven leadership experience in software quality assurance, with a focus on cloud solutions and Embedded Medical Devices (essential)
• Strong understanding of software testing methodologies, tools and processes (essential)
• Familiarity with regulatory standards and compliance requirements for Medical Devices (e.g., ISO 13485, FDA regulations, EN62304) (essential)
• Leadership experience in software risk management, 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 (desirable)
• 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 (desirable)

Qualifications

• Bachelor’s degree in computer science, engineering, or a related field.
• Relevant certifications in software quality assurance or testing (e.g., ISTQB).
• Demonstrated experience in a similar role, preferably within the medical device industry.

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.