System Engineering Manager

ABOUT ORGANOX:

Organ Ox 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. Organ Ox 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.

The System Engineering Manager provides strategic, technical and project execution leadership for the System Engineering Team. Fostering a culture of innovation, technical excellence and delivery responsibility; enabling efficient development of cutting-edge Class 3 Medical Devices in an ISO 13485, 21 CFR PART 820 and MDR quality management system environment.

This is an on-site role based in Oxford, with flexibility, managing a team of employees also based at Oxford and additional external resources where required by the project.

• Establishing and supporting effective team organisational structure, roles, operational mechanisms and infrastructure
• Ensuring communication to/from team members, amongst the team, with stakeholders and other teams within the organisation
• Author and execute a roadmap of developments to improve the System Engineering function
• Resource planning for the headcount, role types, allocation and utilisation optimisation decisions to ensure activities are adequately staffed
• Identification and justification of vacancies, conducting interviews, evaluating candidates, making hiring recommendations, onboarding new recruits and conducting their probation
• Maintain an overview of the Knowledge,
  
  Skills and Abilities
  
  of the team, developing training plans to address gaps and enhance members capabilities
• Financial forecasting and spend tracking against approved department and project budgets
• Contributing to performance metrics and their review, identifying improvement opportunities and implementing development plans
• Critical system engineering decisions based on analysis, trends, and insights to mitigate risks and capitalise on opportunities within the product roadmap
• Supporting team members in their Professional Accreditation under appropriate institutions
• Adhere to the letter and spirit of Organ Ox's Code of Conduct and all other company policies

• System Engineering approach across the product and project portfolio, incorporating the needs of relevant standards, defining essential criteria across a range of attributes including function, performance, safety, interface and reliability
• Appropriate system design and compatibility to enable modular, testable, transferrable and maintainable System, Mechanical, Electronic, Software and Digital Health designs.
• SOP & WI that enable System Engineering. Including Plans, User Needs and analysis, System Architecture, System Requirements, Risk Analysis, System Design and testability of modular platforms through complete and accurate analysis, reporting and records
• Selection, development and qualification of System Engineering tools and systems
• Approval and coordinated delivery by the team of work packages, to achieve project goals and scope
• Cross functional collaboration of the team across the business, with external stakeholders and expert consultants
• Approval of System Engineering DHF (Design History File), DMR (Device Master Record) and DHR (Device History Record) records

• Proven experience in developing system architecture and design; with stratified,…