Senior Tech Transfer Engineer

About Organo

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Organ Ox 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 throughout the world. The company's first product, the Organ Ox

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.

• 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…