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 / transfer phase. The Industrialization Engineer reports to the Director of Operations.

The Industrialization Engineer’s main missions include :

• Managing industrialization projects :
o Elaborate industrial product specifications based on R&D technical specs, marketing requirements, quality & regulatory requirements, logistics, etc.
o Evaluate and select suppliers for raw materials or subcontracted products, together with Purchasing department
o Transfer R&D protocols onto Production tools, and validate performance on prototypes or pilot batches
o Validate scale-up of manufacturing operations
o Optimize Product or manufacturing processes according to specifications
o Drive the qualification and implementation of new methods or equipments
o Create or validate quality documentation associated with the product / process
o Plan and follow-up 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:
o Share 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

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

Our ideal candidate:
• Has a PhD or master 2 level / engineering degree in the medical device field, in Instrumentation, Microfluidics, Mechanics, Electronics or Chemistry
• Has one or more successful experiences taking part in the development and industrialization of a medical device (instrument & consumables)
• Has a good knowledge of quality & regulatory standards in the field, ex. ISO 13485, IVDD or IVDR, ISO 23640 (stability studies)
• Familiar with Production and Industrial environments, quick operational projects
• Capacity to manage suppliers and impact production teams
• 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