Senior Tech Transfer Engineer

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 fulfill 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

We are seeking a highly skilled and motivated Senior Tech Transfer Engineer to drive and execute the operational responsibilities required for successful delivery of new product introductions and company change projects.

The Senior Tech Transfer Engineer will work in the Technology Transfer (TT) Department and will partner with internal and external functions to successfully develop and create new company product streams, mostly through the support of prototype manufacture. These prototypes will then need to be successfully tech transferred into routinely manufactured units at external CDMO's.

The Senior Tech Transfer Engineer will also lead operational elements of change management. This will involve Creation of Change Controls (CC) and the approval within the CC Review Board format. Driving and leading CC activities and ensuring successful roll out of the changes within the company. This will be achieved by managing Engineers and ensuring seamless creation and updates to production processes & documentation, whilst ensuring regulatory compliance leading to full continuity of supply.

The ideal candidate will have a strong background in project management, Change management, medical device manufacturing, and cross-functional collaboration (between internal teams and external partners) which will deliver results on time and within scope.

This is an on-site role in Oxford with flexibility, and occasional travel to supplier & CDMO sites.

Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the Senior Tech Transfer Engineer will be expected to complete additional tasks reasonably requested by the Continuous Improvement & New Product Introduction Manager or Senior Leadership Team.

Major Responsibilities

Under direction of the Continuous Improvement & New Product Introduction Manager, the Senior Tech Transfer Engineer will be responsible for:

• Leading the departmental engineers & technicians to support engineering development & creation activities relating to New Product Introduction (NPI) and ensure any changes required by any company department have a complete and robust “Roll Out” architecture in place so the change is successfully delivered.
• Providing Design Review (DFx) on prototypes from a manufacturing and servicing perspective.
• Work with the PMO team to lead the end-to-end project management of suitable projects, including planning, execution, risk management, and reporting.
• Lead the end-to-end project management of the change, including planning, execution, risk management, and reporting.
• Coordinate cross-functional teams including R&D, Quality, Regulatory Affairs, Supply Chain, and external partners to ensure successful execution of change.
• Ensure all change related process validations, equipment qualifications, and method changes are completed in accordance with regulatory and quality standards.
• Creating and reviewing Specifications, Standard Operating Procedures and Work Instructions, working closely with the Quality department to ensure compliance with relevant medical device regulations.
• Drafting and executing validation and qualification protocols for production and test equipment, along with relevant processes used in manufacturing and servicing.
• Assisting with Root Cause Analysis investigations and any resulting CAPA.
• Manage risk assessments, mitigation strategies, and issue resolution throughout the project lifecycle.
• Serve as the main point of contact for internal stakeholders and external manufacturing partners.
• Provide regular updates to senior leadership 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 contributing towards the sites Health, Safety, Environmental and Sustainability requirements and targets.
• Assisting with general duties associated with a busy, expanding site.
• Ensuring adherence to OrganOx’s Code of Conduct and all relevant company policies.

Requirements:
Skills and Experience

• Proven experience in Project & Change Management in the medical device or life sciences industry
• Good working knowledge of the Safety, Quality and Regulatory Standards applicable (ISO 14971, IEC 60601, ISO 13485 etc) to manufacture of medical devices (desirable).
• Good practical skills and experience in the manufacture, release testing and servicing of safety-critical devices (desirable).
• Proficiency in project management tools (e.g, MS Project, Smartsheet, or equivalent).
• Experience working with QMS / Change Control frameworks desirable.
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
• Experience with process change, validation, equipment qualification, and method transfer.
• Experience of directly managing teams (as well as dotted line influencing of other Project stakeholders)
• Experience writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation.
• The ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
• Familiarity with risk management tools such as FMEA and control plans.
• Proven strong knowledge and understanding of formal engineering/process principles and techniques.
• 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.
• The ability to evaluate, explain and simplify complex technical issues.
• Strong and concise communication skills, both verbal and written.
• Willing and able to travel outside UK on occasion (less than 10% of time).

Qualifications

• A degree/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).
• PMP / PRINCE2 certification or equivalent project management training (desirable).
• 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.

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.