About our Client
Our client, Intressa Vascular is a clinical-stage company developing the only comprehensive treatment for aortic dissection designed to improve patient outcomes with a low risk of ischemic complications.
Using the Allay® Aortic Stent and its proprietary multilayer braiding technology platform, in combination with personalized procedure planning, Intressa Vascular is dedicated to helping physicians address the devastating effect of aortic dissections by providing next-generation endovascular treatment.
Intressa Vascular is currently looking for an Industrialization Manager to strengthen their team.
Your role
Reporting to the Operations Director, the Industrialization Manager is responsible to develop, implement, qualify, validate, maintain and improve manufacturing processes, including special processes such as cleaning, assembly, packaging and sterilization and cleanrooms, to ensure the product quality meets to highest medical standards. His / her objective is to establish capable manufacturing processes that enable the company to produce high-quality products according to appropriate process risk analysis, process monitoring and controls.
The Industrialization Manager's job is a senior position with hands-on responsibilities and team leadership, at the intersection of process engineering, equipment qualification, process validation, quality management and project management. He / she takes part in operational planning and decisions. He / she participates in the growth and future projects of the company.
He / she is responsible, in a proactive and objective-driven manner to:
- Develop industrial plans that contribute to master manufacturing processes and equipment, including validation of special processes, to improve product quality and optimize industrial workflows to meet high-quality standards
- Define and lead “right-first time” process implementation projects according to change management principles
- Manage, plan, and monitor industrial development and process validation projects in collaboration with his / her operational team in managing priorities, task distribution, and skill development.
- Analyze process capability and enhance current production processes, identify product defects and process bottlenecks, identify root-causes and potential corrective plans, and document process risk analysis, propose process monitoring and controls.
- Ensure and document that production processes comply with all quality, safety and environmental (HSE) standards.
- Participate in new product development and transfer to manufacturing
- Propose recommendations for lean improvement and assess new processing technologies to stay ahead of market trends.
- Coordinate multi-disciplinary teams (engineering, maintenance, quality, logistics) to ensure smooth integration of new processes or modifications.
- Perform any additional duties as directed by the company strategy.
Your profile
- Industrial or Civil Engineer in the fields of Mechanics, Electromechanics or Biomechanics.
- Minimum 7 years’ experience in medical industrial environment, in developing and validating (special) manufacturing processes in the medical device or pharmaceutical sector; prior experience with medical implants is a strong asset.
- A good knowledge and understanding of process risk management and product quality management principles (ideally ISO 13485 – ISO 14971 – GMP/GLP).
- Structured, organized and team-oriented, able to collaborate effectively both with his team and transversally.
- Analytical, critical mindset to continuously improve processes according to plan-do-check-act.
- Roll-up-your-sleeves, feet-on-the-ground attitude, autonomous and hands-on mindset.
- Excellent interpersonal, communication, writing and presentation skills, fluent in French and good command of English both written and spoken.
- Experience in industrial lean improvement projects (including KPI, Lean, Six Sigma, etc.) is a plus.
Person in charge
Mélodie Dumoulin - Recruitment Consultant
Office : +32 010 39 21 83 / +32 475 63 39 28
Mail : mdumoulin@plusonesearch.be
