Software Quality Engineer

About the Company

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. A spin-out from the University of Oxford and part of the Terumo Group, OrganOx is a pioneer in normothermic machine perfusion (NMP).

Responsibilities

• Assure software quality through the full lifecycle process in accordance with OrganOx software standards and procedures up to class C according to IEC 62304
• Complete relevant documentation and verification test reports for OrganOx devices and systems
• Assist in design and risk review of new and existing medical devices
• Support and conduct risk assessments and failure mode and effects analysis (FMEA)
• Adhere to company policies and the Code of Conduct

Requirements

• Experience in quality assurance of software for medical devices or other regulated industries
• Knowledge of C language and C coding guidelines (e.g., MISRA)
• Familiarity with regulatory requirements such as IEC 62304, ISO 13485, ISO 14971, and 21 CFR Part 11
• Experience with automating software development practices (e.g., CI/CD, Jenkins)
• Degree in software engineering, computer science, or a related scientific discipline
• Ability to work in a waterfall software development lifecycle environment

Preferred Qualifications

• Knowledge of software quality metrics like code coverage
• Experience with tools such as STM32CubeMx, IAR Embedded Workbench, WindRiver Work Bench, MPLAB X, or Eclipse
• Experience with static analysis tools like Lint