Medical Device R&D Engineer

4 weeks ago

Oxfordshire, United Kingdom OrganOx Full time

Do you want to grow your career with an innovative, fast-paced and rapidly growing medical device company? 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 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.


~ 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. Working within a small, multi-disciplinary team of engineers, including electronics, mechanical and software development, the post holder will develop test protocols and create test harnesses to evaluate components and report on their findings. 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.

Ideally 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.
Ability to work across a range of projects simultaneously.
A first degree or equivalent qualification/experience in Electronic, Mechanical, Biomedical, or general engineering, or other relevant discipline.

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