Senior R&D and Test Engineer MedTech

Bypass Solutions, a MedTech startup based in Marseille, France developping innovative vascular peripheral implants, is growing and is opening a new position in its R&D team.You are willing to participate to the development of first-of-its-kind vascular technologies to improve patient's life? let's apply for this Senior R&D and Test Engineer position.ResponsabilitiesYou will work in the field of interventional vascular devices, including among others catheters and complex implant delivery systems.As a technical lead, you will spearhead the design and prototyping of innovative medical devices and clinical procedures (CAD, 3D printing, prototyping, part inspection, risk management, inventory management, and proposing manufacturing improvements and tooling that meet product-related regulatory requirements) to achieve proof of concept and, subsequently design freeze.You apply state-of-the-art knowledge and techniques in plastics and metallurgy for the design of complex devices, covering materials, manufacturing technologies, assemblies, and design-for-manufacturing principles.You develop specific test methods, using test benches or other models, to verify the performance and safety of the prototypes, products and clinical implantation procedure.You participate in developing product V&V plans and conducting tests (in-house or outsourced) for the qualification, control, verification and validation of products and processes.QualificationsMechanical or biomedical engineerAt least 8 years of experience in the Medtech industryAt least 3 years of experience on interventional cardiovascular devices (catheters, delivery systems, transcatheter systems)Proven capacities to design, develop and test complex transcatheter systemsCAD software: SolidWorksKnowledge and competencies in Design Control and associated regulatory requirements (MDR, QMSR, ISO13485, ISO25539-1) and Risk Management (ISO14971)Fluent in spoken and written English and FrenchStrong writing skills, particularly within a highly regulated environmentHigh organizational, hands-on and attention to detail skillsAutonomy, team spirit, agility, resilience and leadership are essential qualities for success in this role and for career progression within the company