The Industrialization Engineer gets involved in all phases of product development, making sure that operational aspects are covered and anticipated prior to the transfer from R&D to Manufacturing, and takes the lead on a project during the industrialization phase. The Industrialization Engineer reports to the Director of Operations.
The Industrialization Engineer’s main missions include :

• Managing industrialization projects :
o Evaluating and selecting suppliers
o Elaborating industrial specifications based on R&D technical specifications, marketing requirements, quality and regulatory requirements, logistics, etc.
o Supervising development and industrialization phases outsourced or in-house
 Process or product optimization according to specifications
 Qualification and implementation of new methods or equipments
 Validation of prototypes or pilot batches
o Creating quality documentation associated with the product / process
o Planning and follow-up of stability studies, repeatability/reproducibility and any other study necessary to verify product performances for its regulatory registration
o Take part in the supply & quality agreement elaboration and implementation
o Ensure scientific watch on industrial processes / technologies involved for the product manufacturing

• Promoting the results achieved by :
o Sharing results through oral/written presentations, technical reports, production files, etc.
o Record innovative manipulations, results, ideas, optimizations of methods which could lead to a patent filing

• Managing the project team in a matrix organization
o Drive and coordinate team members, including R&D, Operations, Marketing/Sales and Quality Assurance resources
o Ensure an effective interaction between departments and smooth information transfer
o Manage the project using Agile methodology

Our ideal candidate:

• Has a master 2 level or engineer degree in the biomedical field, in Molecular biology or biochemistry with a specialization in medical devices development or industrialization
• Has one or more successful experiences taking part in the development and industrialization of a medical device, preferably reagents or IVD assays
• Has a good knowledge of quality & regulatory standards in the field, ex. ISO 13485, IVDD or IVDR, ISO 23640 (stability studies)
• Capacity to manage suppliers and accompany quality audits
• Team spirit, with excellent communication skills
• Is pro-active, autonomous and rigorous
• Likes to interact with multiple teams and interfaces
• Ability to manage transversally
• Must speak French and English fluently