Verification and Validation Engineer (M/F)
FineHeart S.A, an innovative start-up in the cardiac field, is located in Pessac, in the Bordeaux metropolis. Its new medical device, the ICOMS (Intra Cardiac Output Management System), is an intracardiac pump, allowing patients suffering from severe heart failure to complete their native ejection fraction per cardiac cycle. This device combines the expertise of two famous cardiologists and the know-how of talented engineers in the mechanical, electronic and automatic fields.
- Description of the function
- The Verification and Validation Engineer will be in charge of implementing the verification and validation strategy of ICOMS. To do so, he/she will participate in the elaboration of verification and validation plans. He/she will be in charge of writing the verification and validation protocols. These will cover functional, performance and security aspects of the product.
- He/she will carry out tests on the ICOMS product and write the associated test reports.
- Additional missions may be added in relation to the realization of test benches for the tests to be performed.
Skills and profiles sought
- Qualifying degree in mechatronics or biomedical engineering or equivalent
- Minimum 2 years experience in the medical device sector
- Knowledge of EN ISO 13485 and 21 CFR part 820, ISO 14708-5, ISO 14708-1, IEC 60601-1-2
- Writing of test protocols in English for complex devices (mechanical, electronic, software)
- Preparation and implementation of tests
- Writing of test reports in English
- Ability to work in a start-up environment
- Team spirit
- Fluent in written and read English
- Good capacity of analysis and synthesis
- Writing skills