Senior Medical Devices R&D Engineer

Do you want to grow your career with an innovative, fast-paced and rapidly growing medical device company? OrganOx is committed to developing products that save lives by making every donated organ count. Our dynamic team strive to achieve excellence in the field of organ transplantation, and you could be part of our exciting journey.OrganOx is in the process of expanding its engineering capability and is seeking an enthusiastic Senior Medical Device Research and Development Engineer to join the Product Engineering team.As part of a small multi-disciplinary Product Engineering team, the successful candidate will have responsibility for activities focused on the existing product range in the following areas:Lead root cause analyses of field performance issues. Manage, and qualify component and design changes to support improved manufacturing yield or system performance. This will require close partnership with field-based customer service, operations, and quality teams.Implementing, and verifying design changes relating to product enhancements, and new features and functionality requested by clinical customers.Resolving component obsolescence issues on the existing OrganOx product. Supporting the creation of assembly instructions and outputs required by the Operations team, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs.Working closely with Product Development and Innovations teams throughout development projects with a focus on supporting design reviews and design transfer activities.The ideal candidate will have strong background in relevant science or engineering discipline.The successful candidate will work within a small, multi-disciplinary team of engineers, including electronics, mechanical and software development.The post holder will lead activities relating to design changes and develop test strategies to ensure all changes are effectively implemented.They will support the wider team in ensuring compliant design and verifying performance.The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities.Major Responsibilities: Leading design changes to support product, production and quality improvements. This includes conducting problem-solving efforts and root cause analysis, and the identification and definition of design changes driven by component obsolescence or supply chain.Investigating device performance issues, determining, and reporting the root cause (in collaboration with the quality, service and operations departments), and recommending corrective actions.Interpreting and understanding the product’s intended use, clinical procedures, customer needs and design inputs.Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record.Following, learning, and contributing to R&D procedures, such as failure analysis, design controls and risk management, per the Quality Management System.Assisting prototyping efforts and bench testing.Prepare reports and conclusions for presentation.Ensuring compliance with design and development procedures and ensuring all associated documentation is complete in accordance with ISO 13485 and local procedures.Skills Required: 5+ years’ experience within Research and Development, preferably within medical devices or another highly regulated industry.Experience with electro-mechanical devices, with understanding of how to drive, interface with and troubleshoot devices.Ability to design, implement and carry out experimental test plans for electronic, mechanical, or fluid components, sub-systems, and complete safety-critical systems.Ability to produce Technical Reports to a high standard both in terms of technical content, presentation, and written English.Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team.Ability to work effectively with outside suppliers and manufacturers.Ability to work across and manage a range of projects or tasks simultaneously.We recruit and retain the best people from a broad range of diverse backgrounds who share our values of innovation, evidence, integrity, teamwork, respect and passion. If this sounds like you, and you’re looking for somewhere to grow, develop and thrive, we want to hear from you.