OrganOx
Senior Design Assurance Engineer
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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 Senior Design Assurance Engineer is responsible for ensuring that OrganOx products meet the highest standards of safety and regulatory compliance through robust, lifecycle-long risk management activities. This role focuses on maintaining and improving the risk management process in accordance with ISO 14971, supporting design teams in identifying, evaluating, and controlling risks, and ensuring that risk documentation is complete, consistent, and audit-ready.
The successful candidate will join a rapidly growing Quality department and play a key role in shaping the risk management approach for both new and existing products.
This is a flexible, on‑site role in our Oxford facility, working closely with R&D, Engineering, Post‑Market Operations, and Quality teams to ensure effective control of design, development, risk assessment, and change control.
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Major Responsibilities
Under direction from the Design Assurance Manager, the Senior Design Assurance Engineer (Risk Management) will:
- Lead and maintain risk management activities throughout the full product lifecycle in accordance with ISO 14971 and OrganOx procedures for Class II & III medical devices.
- Develop, update, and maintain risk management files, including hazard analyses, FMEAs, fault trees, benefit–risk assessments, and risk traceability.
- Facilitate and document risk reviews for new and existing devices, ensuring cross‑functional input and alignment with regulatory expectations.
- Support verification and validation activities by ensuring risk‑driven test coverage, reviewing protocols and reports, and confirming that risk controls are adequately verified.
- Monitor post‑market data (complaints, field performance, CAPA inputs) to ensure risks remain acceptable and design files remain current.
- Ensure compliance with global regulatory requirements by reviewing standards, supporting audits, and contributing to continuous improvement of the Quality process.
- Collaborate with design teams to ensure Design Assurance principles are adhered to throughout development, including verification planning and documentation quality.
- Contribute to other Design Assurance tasks as required to support the wider Quality function.
- Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.
Skills and Experience
- Strong written and verbal communication skills.
- Ability to work effectively in a multi‑disciplinary environment.
- Proven analytical and problem‑solving skills.
- Experience in risk management for medical devices or other regulated industries.
- Strong familiarity with ISO 14971 and risk-based approaches to design and development.
- Experience working in both software risk and cybersecurity risk assessment. (Desirable)
- Experience with domestic and international regulatory requirements and regulatory bodies. (Desirable)
- Experience working within a quality management system and following standard operating procedures.
- Demonstrated ability to coach, mentor, or guide colleagues in technical topics.
- Ability to work to strict timescales and adapt to changing priorities.
- Experience reviewing regulatory standards and ensuring procedural compliance.
- Experience participating in design reviews and supporting full product development lifecycle activities.
- Experience working in Quality within the medical device industry. (Desirable)
- Background in Class II or Class III medical devices. (Desirable)
- Experience with post-market surveillance inputs to risk management. (Desirable)
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Qualifications
- A degree in bioscience, engineering, or a related technical field.
- Ability to travel as required for project activities.
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.
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