About our Client

Our client Intressa Vascular is aclinicalstage company developing the only comprehensive treatment for aorticdissection designed to improve patient outcomes with a low risk of ischemiccomplications.

Using theAllay Aortic Stent and its proprietary multilayer braiding technologyplatform in combination with personalized procedure planning IntressaVascular is dedicated to helping physicians address the devastating effect ofaortic dissections by providing nextgeneration endovascular treatment.

IntressaVascular is currently lookingfor an Industrialization Manager to strengthen their team.

Your role

Reporting to the Operations Directorthe Process Development Lead is responsible to develop implement qualifyvalidate maintain and improve manufacturing processes including special processessuch as cleaning assembly packaging and sterilization and cleanrooms toensure the product quality meets to highest medical standards. His / herobjective is to establish capable manufacturing processes that enable thecompany to produce highquality products according to appropriate process riskanalysis process monitoring and controls.

The Process Development Leads job is asenior position with handson responsibilities and team leadership at theintersection of process engineering equipment qualification processvalidation quality management and project management. He / she takes part inoperational planning and decisions. He / she participates in the growth andfuture projects of the company.

He / she is responsible in a proactiveand objectivedriven manner to:

Develop industrial plans thatcontribute to master manufacturing processes and equipment includingvalidation of special processes to improve product quality and optimizeindustrial workflows to meet highquality standards

Define and lead rightfirst timeprocess implementation projects according to change management principles

Manage plan and monitor industrialdevelopment and process validation projects in collaboration with his / heroperational team in managing priorities task distribution and skilldevelopment.

Analyze process capability and enhancecurrent production processes identify product defects and process bottlenecksidentify rootcauses and potential corrective plans and document process risk analysispropose process monitoring and controls.

Ensure and document that productionprocesses comply with all quality safety and environmental (HSE) standards.

Participate in new product developmentand transfer to manufacturing

Propose recommendations for leanimprovement and assess new processing technologies to stay ahead of markettrends.

Coordinate multidisciplinary teams(engineering maintenance quality logistics) to ensure smooth integration ofnew processes or modifications.

Perform any additional duties asdirected by the company strategy.

Your profile

Industrial or Civil Engineer in thefields of Mechanics Electromechanics or Biomechanics.

Minimum 7 years experience in medicalindustrial environment in developing and validating (special) manufacturingprocesses in the medical device or pharmaceutical sector; prior experience withmedical implants is a strong asset.

A good knowledge and understanding ofprocess risk management and product quality management principles (ideally ISO13485 ISO 14971 GMP/GLP).

Structured organized andteamoriented able to collaborate effectively both with his team and transversally.

Analytical critical mindset tocontinuously improve processes according to plandocheckact.

Rollupyoursleevesfeetontheground attitude autonomous and handson mindset.

Excellent interpersonalcommunication writing and presentation skills fluent in French and good commandof English both written and spoken.

Experience in industrial leanimprovement projects (including KPI Lean Six Sigma etc. is a plus.

Person in charge

Mlodie Dumoulin Recruitment Consultant

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