Location: Villeneuve d’Ascq (59) – France
Requested experience: at least 1 year after BAC+5
Gross salary: 29-31k€
Hemerion Therapeutics is a health tech company at a clinical level. Hemerion results of over 10 years of leading academic and clinical researches on innovative approaches to treat Glioblastoma. These new technologies have been evaluated to treat brain cancer through a first-in-human clinical trial. Hemerion owns a unique and disruptive technology, already evaluated in frontline approach to treat patients harboring brain cancer.
Today, Hemerion seeks our test and validation engineer to support our increase activity to verify and validate the performance of our medical device.
To support our increase in activity, we are looking for our medical devices test and validation engineer to verify and validate the performance of our medical device.
Position and responsibilities
Under the supervision of the CEO, the CTO and the medical device R&D manager, you will perform the verification and validation tests of the essential performances of our medical device, defined from all applicable European and American standards. Your missions are the following:
- Analyze the specifications, documentation, and drawings of the prototype to understand the specifications of the device
- Define the measurement tools required for the implementation of the studies
- Participate in the design, calibration, and qualification of test benches
- Participate in the setting up of the metrology of the company’s laboratory
- Carry out validation tests
- Write in English all the associated documentation (test plan, experimentation reports) in accordance with our quality system
- Participate in the elaboration of the verification and validation file of the medical device
- Contribute to the activity of our quality system
- Contribute to the regulatory watch related to our medical device
The position is likely to evolve towards a permanent contract depending on the future activity within the R&D department.
- Good general knowledge of engineering and laboratory techniques of validation tests (including optical and mechanical)
- Excellent rigor, meticulousness, and reproducibility in performing tests
- Excellent ability to interpret and analyze measurement results
- Knowledge of the quality system in the medical field (Europe ISO 13485 version 2016 and US 21CRF820)
- Knowledge of the following standards: ISO 14971, IEC 60601-1, IEC 60601-2-22, IEC 60601-2-75, 10555-1 and -4, 80369-7 and -20.
- Perfect command of written English for daily writing of related documentation
- Good understanding of our therapy (from a medical device perspective)
- Excellent organizational and interpersonal skills
- Ability to work independently
You have a master degree in materials, biomaterials or mechanics. You have at least one year of experience in a test laboratory in research and development in the medical device sector and could take charge of these tests. You will need to be creative and inventive in setting up test benches while considering the regulatory constraints proposed by the applicable standards. You are an organized, autonomous, rigorous, pragmatic person, with a taste for teamwork.
Advantages of the position
- Dynamic environment
- International and growing company