Based in Gembloux, Intressa Vascular is a clinical-stage company developing an innovative medical implant to address life-threatening cardiovascular conditions such as aortic dissection.Our mission is to help physicians address the devastating effect of aortic dissection by providing next-generation endovascular treatment.To strengthen our team, we are looking for a Mechanical Engineer.
Reporting to the Operations Director, the Mechanical Engineer is responsible for the mechanical design, industrialization, technical file maintenance, and technical support of medical devices.The role focuses on delivering robust and reliable mechanical solutions that comply with functional, regulatory, and manufacturing requirements throughout the product lifecycle, from design to verification, validation, and production support.
Design and develop mechanical components and assemblies for medical devices, translating design inputs into robust, manufacturable solutions.
* Support mechanical verification and validation activities, including protocol development, test execution, results analysis, and technical reporting.
* Support the transfer of mechanical designs to manufacturing, ensuring manufacturability, robustness, and production readiness.
* Collaborate with manufacturing, quality, suppliers, and cross-functional teams to resolve technical issues during production and change activities.
* Produce and maintain mechanical design documentation in compliance with ISO 13485 and applicable medical device regulations.
* Contribute to design risk management activities, including hazard analysis, mitigation implementation, and regulatory compliance support.
Engineer or Master's degree in Mechanical Engineering, Biomechanics, Medical Device Design, or equivalent.
* 3 to 5 years of professional experience in mechanical engineering, preferably in the medical device industry or another regulated environment.
* Strong mechanical engineering fundamentals (materials, stress/strain, fatigue, tolerancing).
* Experience in using 3D CAD and reading technical drawings.
* Understanding of Quality Management Systems and Risk Management for medical devices.
* Fluent in French and good command of English, written and spoken.
A challenging and diversified position within a high-potential innovative medical device company.-