Senior R&D and Test Engineer MedTech

BYPASS SOLUTIONS SAS; Marseille; On-site; EUR 90,000 - 130,000; Full time

Job summary

Bypass Solutions SAS, a Marseille MedTech startup, is expanding its R&D team to develop first-of-its-kind vascular implants. You will act as a technical lead for design and prototyping of interventional devices, leveraging CAD, 3D printing, and rigorous testing.

The role requires strong background in mechanical or biomedical engineering, MDR/ISO13485 knowledge, and fluency in English and French. You will drive design-for-manufacturing and risk management in a fast-paced, regulated environment.

Qualifications

• 8+ years of experience in the Medtech industry.
• At least 3 years of experience on interventional cardiovascular devices.
• Fluent in English and French, both written and spoken.
• Solid knowledge of MDR, QMS, ISO13485 and ISO14971.
• Experience with design controls and risk management.

Responsibilities

• Lead design and prototyping of transcatheter systems and vascular devices.
• Develop CAD models, 3D printing, part inspection and tooling proposals.
• Create and execute V&V plans and testing strategies per regulatory requirements.
• Collaborate on manufacturing improvements and risk management activities.

Skills

Medtech experience

Interventional devices

Leadership

Education

Mechanical or biomedical engineer

Tools

SolidWorks

Job description

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?

Responsabilities

• You 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.

Qualifications

• Mechanical or biomedical engineer
• At least 8 years of experience in the Medtech industry
• At least 3 years of experience on interventional cardiovascular devices (catheters, delivery systems, transcatheter systems)
• Proven capacities to design, develop and test complex transcatheter systems
• CAD software: SolidWorks
• Knowledge 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 French
• Strong writing skills, particularly within a highly regulated environment
• High organizational, hands-on and attention to detail skills
• Autonomy, team spirit, agility, resilience and leadership are essential qualities for success in this role and for career progression within the company