System Engineering Manager

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

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.

Listed below are the key responsibilities of the role and a high-level description of key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Director, Systems Engineering, the System Engineering Manager will be responsible for:

• 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 OrganOx’s Code of Conduct and all other company policies.

And Accountable for:

• 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.

Requirements:
Skills & Experience

• Proven experience in developing system architecture and design; with stratified, structured and traced design controls.
• Hands-on experience with IEC 60601 standards.
• Strong understanding of requirement and risk management.
• Proven track record with audits and regulatory submissions, including preparation and presentations to regulatory bodies.
• Excellent project management skills and the ability to manage multiple priorities in a fast-paced environment.
• Demonstrable background in software driven mechatronic devices, precision control and hydraulics.
• Proven track record of Class 2 or 3 medical devices and familiarity with the unique challenges in this field..
• Advanced knowledge of medical device design and technologies..
• Vision and knowledge in the field of System Engineering tools and practices such as, ALM (Application Lifecycle Management), MBSE (Model Based Systems Engineering), SysML (Systems Machine Learning)
• Exceptional communication and leadership skills, demonstrating a collaborative approach & mindset.
• Demonstrable knowledge of the regulatory environment, including FDA, IEC 60601, ISO 13485, ISO 62366 and other relevant standards.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Biomedical Sciences or a related field.
• A well established and proven track record in systems engineering within the medical device industry, preferably with Class 3 devices.

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.