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 Architect provides technical and strategic leadership on design, development and test. Driving 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 onsite position based in Oxford with flexibility.
Major Responsibilities
- Author and maintain the System Test strategy and roadmap of developments
- Conducting the analysis, trending and insight generation of insights to identify risks and capitalize on opportunities
- Lead activities for high level system design, through all stages of technical development and across the business structure in with company goals and technology strategies
- Ensuring test design and testability input to enable DfT and DfR of System, Mechanical, Electronic, Software and Digital Health designs.
- Researching technologies and making informed recommendations for their introduction based on best practice and project/company goals
- Comprehensive system test of designs in the product and project portfolio to ensure criteria are met across a range of attributes including function, performance, safety, interface and reliability
- Collaborate with and advise key stakeholders to gather and understand needs and technical specifications, working closely to ensure alignment.
- Supporting, coaching and mentoring engineers across the business in the development of their Knowledge, Skills and Abilities
- System Test Engineering SOP & WI that enable Design Verification and Validation. Including Plans, Sample Sizing, Methods, Protocols, training, execution, analysis and reporting
- Selection recommendations, development and qualification of tools and systems
- Integrating relevant DHF content and technical activities for products across the project portfolio to achieve efficient, compliant delivery.
- Contributing to performance metrics and their review, identifying improvement opportunities and implementing development plans
- Collaborate with colleagues, teams throughout the business and external resources to ensure adherence to architectural guidelines, best practice and timely execution.
- Supporting engineers with completion of the relevant records for test activities in the DHF, DMR and DHR; facilitating the regulatory submission process and ensuring the capability for future development and maintenance of designs.
- Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies
Requirements
Skills & Experience
- Extensive 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 sample size development and statistical justification
- Experience with audits and regulatory submissions, including preparation and presentations to regulatory bodies
- 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.
#J-18808-Ljbffr