Location: Villeneuve d’Ascq (59) – France
Requested experience: +3 years
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, to support the development of our products, we are looking for a Medical Device Development Engineer.
We are seeking a Medical Device Development Engineer to plan, drive and organize our project prototypes, pre-industrialization, and pre-series for upcoming clinical trials clinical trials.
Position and responsibilities
Under the supervision of the Chief Technology Officer, you will be involved in the planification and coordination of medical device development projects from the design phase through to clinical trials. As the main contact with our subcontractors, you will embody the link between the production, sterilization, testing and validation, and clinical sites. You will ensure compliance of the medical device development process with regulatory requirements, Hemerion standard operating procedures and good clinical practices.
Your missions as Medical Device Development engineer are the following:
- To inspire a strong dynamic to our subcontractors and keep project on time and on budget.
- To oversee and ensuring that production of medical devices from design to manufacture are performed in accordance with the MDR 2017/745 and 21 CFR 820 and be able to respond to any audit.
- To support and coordinate projects in parallel with registration activities to provide the necessary documentation for various regulatory submissions.
- Write and maintain a medical device design file.
- To manage, follow-up and closeout all life cycles of the device (conception, development, prototype, pre-serial).
- To participate to set-up the ISO 13485
- To manage day-to-day project activities, including monitoring and updating all documents of the QMS
- Excellent knowledge of medical device development cycle, standards and regulations relating to medical devices in Europe and the US (MDR 2017/45, ISO 13485, 21 CFR 820, ISO 14971)
- To master project management, problem solving, data analysis and risk analysis techniques.
- Fluent in English and French for daily contacts with local and international partners
- Excellent organizational, communication and interpersonal skills
- Ability to work well in autonomy and within a team
You have an engineering or doctoral degree in the fields of mechanics, materials or biomedical, you understand the regulatory requirements related to the design and development of new medical devices (risk management plan, technical file…). You like collaborative work, sharing experiences and want to actively participate in the development of our startup, apply now!
- Dynamic environment with opportunities for advancement within the company.
- International and growing company.
- Luncheon vouchers.
- Full health insurance coverage.