Job Description

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.

The Software Quality Engineer is responsible for supporting software quality assurance by ensuring regulatory compliant software life cycle documentation is produced, confirming adherence to software procedures and coding standards, and participating in software testing. The Software Quality Engineer will be involved in the software quality assurance of the full software development lifecycle of new and existing product. As a medical device company, software documentation and procedures must adhere to the relevant standards under the guidance of the Director of Regulatory Affairs. The Software Quality Engineer will join rapidly growing Quality team and will have a proven track record in software quality assurance. The Software Quality Engineer will report to the Design Assurance Manager.

This is an on-site role in Oxford, with flexibility, to ensure effective control of the design and development, risk assessment, and change control, in collaboration with the R&D, Post-Market Engineering, and Quality teams.

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 Manager, Design Assurance the Software Quality Engineer will:

• 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, according to OrganOx documentation procedures.
• Assist in design and risk review of new and existing medical devices.
• Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
• Contribute as part of the team to assist in other tasks as necessary.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements

Skills & Experience

• Experience in the quality assurance of software for medical devices or other risk compliant/regulated industries.
• Familiarity with the regulatory requirements for medical software for compliance with European and United States quality standards, with practical working knowledge of IEC 62304, ISO 13485, ISO 14971 and 21 CFR Part 11 quality systems (desirable)
• Experience of automating software development practices, e.g., continuous integration/ delivery/ deployment and software tools to support, e.g. Jenkins.
• Knowledge of software quality metrics, e.g. code coverage (desirable)
• Software Development Tools, e.g., STM32CubeMx, IAR Embedded Workbench, WindRiver Work Bench, MPLAB X, mikroC PRO, Eclipse, Cantata (desirable)
• Familiar with complying with standard operating procedures, coding standards, quality management system, etc.
• C language knowledge.
• An understanding of C coding guidelines, rules and directives, e.g., MISRA, and the ability to configure and operate static analysis tools, ideally Lint.
• Exposure to the full software development lifecycle and the ability to review documents across the lifecycle for consistency and traceability.
• Ability to identify risks in software requirements and implementations and assess the severity and probability of occurrence and mitigate risk.
• Experience of reviewing applicable regulatory standards and ensuring that standard operating procedures remain compliant.
• Experience of working in a waterfall software development lifecycle environment, participating in design reviews, and ensuring software lifecycle stage requirements are met.
• Microsoft Office applications, ideally Office 365.
• Good communication skills and written English.
• Ability to work effectively in a multi-disciplinary team.
• Have a proven track record of analytical problem-solving skills.
• Working to strict timescales and being flexible to achieve.

Qualifications

• A degree in software engineering, computer science, information engineering or other related scientific discipline.

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.