Maintenance and Validation Engineer

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 delivering next-generation endovascular treatment.

To strengthen our team, we are looking for a Maintenance and Validation Engineer who will play a key role in internal standards and applicable regulations.

Job purpose:

Reporting to the Operations Director, the Maintenance and Validation Engineer is responsible for ensuring that all production and testing equipment is properly maintained, qualified, and documented, in line with internal standards and applicable regulations. He/she contributes to operational excellence and quality assurance by managing equipment lifecycle, coordinating maintenance activities, and supporting validation and continuous improvement initiatives.

Duties and Responsibilities:

He/She is responsible, in a proactive and results-driven manner to:

- Perform and document preventive and corrective maintenance of production and testing equipment, ensuring operational continuity and compliance.

- Coordinate equipment qualification activities (IQ/OQ) and maintain up-to-date technical documentation and maintenance plans.

- Manage equipment lifecycle records and ensure traceability of interventions, non-conformities, and corrective actions.

- Draft and maintain SOPs, qualification reports, and equipment logbooks in alignment with ISO 13485 and CE marking requirements.

- Support project teams in the selection, installation, and validation of new equipment.

- Contribute to internal and external audits and drive continuous improvement through technical monitoring and CAPA support.

Profile:

- Degree in industrial engineering, in the fields of mechanics, electromechanics, biomechanics or any equivalent degree.

- 3 to 5 years of relevant experience in an industrial environment, preferably in the medical device industry.

- Strong knowledge and hands-on experience in IQ/OQ qualification and equipment lifecycle monitoring.

A good knowledge and understanding of process risk management and product quality management principles (ideally ISO 13485 – ISO 14971 – GMP/GLP).

- Proven experience with the selection, commissioning, and validation of new equipment.

- Autonomous, hands-on mindset with a proactive and problem-solving attitude.

- Excellent communication skills (written and verbal), with strong analytical abilities.

- High level of attention to detail, excellent organizational skills and time management.

- Fluent in French and English, both written and spoken.

Our offer:

- A challenging and diversified position within a high-potential innovative medical device company.

- A human-sized, collaborative, and respectful work environment.

- An attractive compensation package in line with the position responsibilities and your experience.