Senior Medical Device R&D Engineer
3 weeks ago
ABOUT ORGANOX:
OrganOx has been transforming organ transplantation since 2008, leveraging ground-breaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 24 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion, we seek an experienced Senior Medical Device R&D Engineer to join our team.
Position Summary
OrganOx is in the process of expanding its engineering capability and is seeking an enthusiastic 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.
Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed.
Major Responsibilities
The Medical Device Research & Development Engineer will be responsible for:
- 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 and Experience
- 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.
Qualifications
- A first degree or equivalent qualification/experience in Electronic, Mechanical, Biomedical, or general engineering, or other relevant discipline.
- 5+ years of experience of working in a similar role.
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 race, colour, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
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