FineHeart S.A, French medical device company focused on creating innovative technologies in the cardiovascular space, is located in Pessac, in Bordeaux’ metropolis. The patented FineHeart invention, the ICOMS (Implantable Cardiac Output Management System) is a novel, wirelessly powered, fully implantable mechanical circulatory support device that is able to optimize cardiac output while preserving the heart’s innate contractility. It is a game changing therapy for long term circulatory assistance in severe heart failure patients.
FineHeart was founded by a team of four internationally renowned cardiac surgeons and cardiologists, led by Dr. Stéphane Garrigue (ICOMS Inventor) and Dr. Philippe Ritter, co-inventor of cardiac resynchronization therapy, with a vision of making a miniaturized, fully implantable, pulsatile circulatory support system that would overcome many of the challenges associated with left ventricular assist devices (LVADs) currently on market. The overarching goal is to restore normal cardiac output and allow heart failure patients to return to a normal quality of life.
In the context of its expansion, FineHeart currently searches for a manufacturing / process engineer (senior)
The manufacturing / process engineer will be fully integrated in the realization and organisation of the development medical device products class III implantable active.
Under the responsibility of the CTO, the manufacturing / process engineer will be responsible for the mechanical manufacturing processes of the ICOMS project. This contains internal manufacturing processes and as well the management of external manufacturing partners. Manufacturing processes need to be verified / validated, this will be performed by the manufacturing / process engineer.
Your missions will be (non-exhaustive list):
- primarily responsible for the development of manufacturing processes of mechanical parts (mainly titanium), including machining, polishing, assembling, cleaning, packaging and sterilization.
- develop adequate inspection methods for each of the processes.
- prepare and perform process validation and / or define testing level for not validated processes.
- manage subcontractors
- support the development of specifications / requirements
- participate in process risk analysis
- support mechanical engineering and product development teams
Researched profile and skills
- Person from a Bac +5 training, preferably in Mechanics or Mechatronics.
- At least 3-5 years experience as manufacturing / process engineer (medical devices class 3 implantable preferred)
- Experienced in managing external partners / subcontractors
- Fluent technical English
- Should be familiar with GMP + pertinent regulatory standards
- Ability to train on a new environment
- Team spirit
Job Types: Full-time, Permanent