Introduction:
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.
Job purpose:
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.
Duties and Responsibilities:
He/she is responsible, in a proactive and objective-driven manner to:
- Design and develop mechanical components and assemblies for medical devices, translating design inputs into robust, manufacturable solutions.
- Manage mechanical design changes and maintain consistency between design inputs, outputs, risk management files, and technical documentation.
- Support mechanical verification and validation activities, including protocol development, test execution, results analysis, and technical reporting.
- Ensure full traceability between requirements, design outputs, and verification/validation evidence.
- 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.
Profile:
- 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.
- Knowledge of verification and validation principles.
- Understanding of Quality Management Systems and Risk Management for medical devices.
- Familiarity with applicable regulations and standards (EU MDR 2017/745, ISO 13485; ISO 25539-2 is an asset).
- Hands-on, autonomous and methodical working style.
- Strong organization, time management, and analytical skills.
- Good communication and technical writing skills.
- Ability to collaborate effectively with internal and external stakeholders.
- Fluent in French and good command of English, written and spoken.
Our offer:
- A challenging and diversified position within a high-potential innovative medical device company.
- Working in a human-sized, collaborative, and respectful environment.
- An attractive compensation package in line with the position responsibilities and your experience.