Medical Device Test Engineer
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 a motivated Medical Device Test Engineer to join our team.
Position Summary
OrganOx is in the process of expanding its engineering capability and is seeking an enthusiastic Medical Device Test 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;- Planning and creating test strategies and test plans to support verification activities and design change submissions
- Verifying design changes and new features
- Assisting in root cause analyses of field performance issues. This will require close partnership with field-based customer service, operations, and quality teams.
- Ensuring test and laboratory equipment is well maintained and calibrated in accordance with QMS requirements
- Developing test rigs and fixtures, and procurement of test equipment
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 develop test protocols and create test fixtures 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.
Major Responsibilities- Complete bench testing and verification activities, including supporting devices at external test houses, and conducting other bench tests where appropriate.
- Assist in the assembly of prototypes and test fixtures for components.
- Create verification and validation test plans alongside R&D Engineers and Quality Assurance team.
- Support root cause analysis, which will be used to feed test results/failures back into the design process.
- Ensure test and laboratory equipment calibration is maintained
- Assist in maintaining the laboratory area, and procurement of test equipment
- Ensure compliance with ISO 13485/FDA regulatory requirements and applicable test standards
- Develop test protocols and document all activities within our Quality Management System.
- Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams to support design change and QMS documentation.
- Ability to produce Technical Reports to a good standard both in terms of technical content, presentation and written English, ready for subsequent review
- Enthusiasm, good communication skills and ability to collaborate effectively in a multi-disciplinary team
- Practical experience in verification of medical devices within an ISO13485/21CFR regulated environment.
- Experience in writing test protocols aligned with Product Requirement Specifications.
- Experience in medical device development and design change control.
- Hands-on experience in an ISO13485/FDA-regulated environment.
- Strong background in the development and execution of verification and validation protocols.
- Hands on experience of build and test of electro-mechanical devices.
- A degree in Science or Engineering or equivalent relevant experience.
- Familiarity of medical device standards (Electrical Safety BS EN 60601, including 60601-1-2 EMC)
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.