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Product & Industrialization Development Manager - Cardiovascular MedTech - Namur

Company

Our client is a medical device company, specialized in innovative treatments for cardiovascular diseases. The company has developed a new generation of breakthrough stents. This technology is in the commercialization phase, with potential new therapeutic applications in clinical development.

The company is located between Namur and Charleroi.

To support the development of the company, we are looking for a (m/f):

Role

As Product & Industrialization Development Manager, you are responsible to define, evaluate, industrialize, validate, maintain, and improve production processes. Reporting to the VP Operations, you will manage key performance indicators of production processes and will provide recommendations on process controls and potential improvements. You will collaborate with the R&D, Production, Maintenance and Quality / Regulatory departments to carry out industrialization studies, scale-up and validation plans for production processes. You will contribute to continuous improvement of supply chain processes (productivity, quality, ergonomics and safety) in a Six-Sigma and Lean Manufacturing spirit. From the start, this position will gradually evolve towards the role of Vice President Operations.

Your main responsibilities are:

  • To ensure industrialization and validation of production processes, including special processes, to meet applicable regulatory requirements for the production of implantable devices.
  • To improve production processes to increase their reliability, yield and productivity, and facilitate the evolution of the work environment (including its ergonomics and safety) to increase product performance.
  • To ensure the identification, analysis and management of process-related risks impacting the product, including the management of technical know-how and manual operations, and the implementation of methods of risk controls.
  • To analyze technical and product manufacturing data, in-process control data, key process performance indicators.
  • To participate in the analysis of market feedback (eg. non-conformities, complaints, feedback), and implement process-related corrective actions.
  • To provide recommendation on the process improvement (productivity, quality, ergonomics and safety) associated with production activities.

Profile

  • Industrial or Civil Engineer in the fields of Mechanics, Electromechanics or Biomechanics.
  • At least one previous experience in leading a small team or resources on projects and the willingness to progress gradually into a leadership role.
  • 7 to 10 years’ experience in an industrial environment, in the medical device (preferred), pharmaceutical, cosmetic, agronomical or aeronautic sector.
  • Hands-on experience and practice in industrialization and validation of production procedures and process measurement methods, applying industrial methodologies (design and improvement of processes and workstations operating times, ergonomics).
  • Knowledge and understanding of risk management and quality management system principles (ideally ISO13485 - ISO 9001 - GMP / GLP).
  • Knowledge of statistical analysis methods, Six Sigma Lean Manufacturing (Green Belt) is an asset.
  • Analytical, critical mindset in order to continuously improve processes.
  • Roll-up-your-sleeves attitude, autonomous and hands-on mindset.
  • Excellent interpersonal, communication, writing and presentation skills.
  • Able to work and collaborate effectively with internal and external actors to achieve company objectives.
  • Fluent in French and good command of English, written and spoken.
  • Willing to travel abroad occasionally.

Offer

  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • The position located between Namur and Charleroi with part time travel to visit clinical sites.
  • An attractive compensation package in line with the position responsibilities and your experience.

Publication date

15.05.2022

Contact person

Sophie Gravy

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