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 throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
Position Summary
The Systems Test Engineering Manager provides strategic, technical and project execution leadership for the System Test 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.
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.
This is an on-site position in Oxford with flexibility.
Major Responsibilities
Under direction from the Director, Systems Engineering, the Systems Test Engineering Manager will be responsible for:
* Establish and support 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.
* 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 test 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.
* System test of designs across the product and project portfolio to ensure criteria are met across a range of attributes including function, performance, safety, interface and reliability.
* Appropriate test design and test input to ensure DfT and DfR of System, Mechanical, Electronic, Software and Digital Health designs.
* SOP & WI that enable Design Verification and Validation. Including Plans, Sample Sizing, Methods, Protocols, training, execution, analysis and reporting.
* Development and qualification of System Test Engineering tools and systems.
* The 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 test houses and expert consultants.
* Approval of System Test Engineering DHF, DMR and DHR records.
* Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
Requirements
Skills & Experience
* Proven experience in developing test strategies, infrastructure, and tool qualifications.
* Hands-on experience working with external test houses to ensure compliance with IEC 60601 standards.
* Strong understanding of risk management, sample size development and statistical justification.
* Experience 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.
* Experience with software driven mechatronic devices, precision control and hydraulics.
* Experience with Class 2 or 3 medical devices and familiarity with the unique challenges in this field are desirable.
* Advanced knowledge of medical device testing tools and technologies (desirable)
* Exceptional communication and leadership skills with a collaborative 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 testing 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.