Open Stent Solution (OSS) is a medical device company that develops cutting-edge technology for transcatheter mitral and tricuspid valve replacement (TMVR).
These devices are designed to treat high-risk surgical patients with valve regurgitation who are contraindicated for surgery. Mitral regurgitation is one of the most common valve diseases in the U.S. and the EU, resulting from a leaflets coaptation defect. Its prevalence increases with age and heart failure and is responsible for the deterioration of patients' quality of life and reduced life expectancy.
Our goal is to develop a prosthetic valve using rupture technology that can be implanted through a trans-femoral approach using a minimally invasive small-diameter device.
Additional information is available at www.oss.ovh.
Why Join Open Stent Solution?
We are a young, pioneering company developing a patented technology that is a unique world first. To ensure its success we value creativity, proactivity, initiative and teamwork. We work with engineers with a wealth of experience who seek to complement their team with competent professionals who are passionate by their mission. Our environment is entrepreneurial, interactive, fast, and the high-quality work we produce is rewarding and meaningful.
Being part of our team ensures you an exciting and captivating technical adventure. You also will contribute to the creation of a new generation of future devices that will provide an effective therapeutic solution for patients with valve disease and are forgotten by surgery.
In this exciting key role as a R&D Engineering project manager you will have the responsibility for developing cardiovascular devices through Finite Element Analysis, managing the projects, the simulated in-vitro tests and production. You will provide engineering direction to the team with constant interaction with company leadership and key opinion leader physicians. The position is based in our Amiens offices.
Roles & Responsibilities
• Define and optimize cardiovascular device specifications (stent and leaflet) and technology requirements.
• Provide device drawings and documentation in compliance with our quality system.
• Plan and manage device production, validate processes with the suppliers.
• Design best spoke durability testing apparatus and perform device test plans and simulations.
• Ensure compliance with standards and regulations with the Quality and Regulatory team.
• Taking initiative to propose a strategic development plan for the technology with constant device improvements.
• Maintain a broader view than current role, demonstrate 360° thinking in decision-making and consider the needs of the entire organization.
Qualifications & Education Requirements
• You will have a PhD in Numerical Modeling (FEA, CFD). A minimum of 5 years of experience in the medical device industry is highly valued, with expertise in Nitinol/Biological tissues/Polymeric materials. Project management skills, cross-functional experience in R&D, Operations and Quality are important.
• Language: fluent in written and spoken English. Open Stent Solution is an English-speaking company.
• Computer skills: ANSYS, DYNA, SolidWorks, Microsoft Outlook, Excel, Word, Powerpoint. Willingness to use new applications.
• Comfortable using databases for patent or literature reviews.
• Willing and able to learn.
• Results oriented.