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 worldwide. The company's first product, the OrganOx metra® normothermic machine perfusion system for liver transplantation, has supported over 5,000 liver transplant operations globally.
Position Summary
We are seeking a highly skilled and motivated Technology Transfer Engineer to execute the operational elements required to successfully deliver company change projects. The role involves creating change controls (CC) and presenting them at the CC Review Board, driving and completing CC activities, and ensuring successful roll‑out of changes within the company. Responsibilities include seamless updates to production processes and documentation, ensuring regulatory compliance, and maintaining full continuity of supply. The ideal candidate has a strong background in project management, change management, medical device manufacturing, and cross‑functional collaboration. This is an on‑site role in Oxford with flexibility and occasional travel to supplier and CDMO sites.
Major Responsibilities
* Ensure any changes required by any company department have a complete and robust roll‑out architecture in place.
* Deliver on the end‑to‑end project management of the change, including planning, execution, risk management, and reporting.
* Ensure all change‑related process validations, equipment qualifications, and method changes are completed in accordance with regulatory and quality standards.
* Create and review specifications, standard operating procedures, and work instructions in collaboration with the Quality department.
* Execute validation and qualification protocols for production and test equipment, along with relevant processes used in manufacturing and servicing.
* Assist with root‑cause analysis investigations and any resulting CAPA.
* Support risk assessments, mitigation strategies, and issue resolution throughout the project life cycle.
* Provide regular updates on project status, risks, and mitigation strategies.
* Ensure all activities align with applicable regulatory standards (e.g., FDA, ISO 13485, MDR).
* Support regulatory submissions and documentation related to the change.
* Collaborate with Quality Assurance to ensure that quality systems and documentation are appropriately updated.
* Actively contribute toward the site’s Health, Safety, Environmental and Sustainability requirements and targets.
* Assist with general duties associated with a busy, expanding site.
* Ensure adherence to OrganOx’s Code of Conduct and all relevant company policies.
Skills and Experience
* Proven experience in project and change management in the medical device or life sciences industry.
* Experience working with QMS/Change Control frameworks is desirable.
* Good working knowledge of applicable safety, quality, and regulatory standards (ISO 14971, IEC 60601, ISO 13485, etc.) to manufacture medical devices.
* Good practical skills and experience in the manufacture, release testing and servicing of safety‑critical devices.
* Familiarity with project management tools (e.g., MS Project, Smartsheet, or equivalent).
* Proven strong knowledge and understanding of formal engineering/process principles and techniques.
* Ability to manage multiple priorities in a fast‑paced, deadline‑driven environment.
* Experience with process change, validation, equipment qualification, and method transfer.
* Experience of “dotted line influencing” of other project stakeholders.
* Familiarity with risk management tools such as FMEA and control plans.
* Good understanding of manufacturing equipment and related systems.
* A hands‑on approach to developing, evaluating, and improving manufacturing processes.
* Collaborative mindset with the ability to work across departments and with external partners.
* Ability to evaluate, explain and simplify complex technical issues.
* Strong and concise communication skills, both verbal and written.
* Willing and able to travel outside the UK on occasion (less than 10% of time).
Qualifications
* A degree or equivalent qualification (in process, manufacturing, mechanical, biomedical or other relevant discipline) or experience in the medical device industry (or a comparably highly regulated industry) – essential.
* Good working knowledge or qualifications in process design and improvement methodologies such as Lean or Six Sigma (Green Belt desirable).
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.
Equal Opportunity Employer
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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