Stilla Technologies

Stilla Technologies

Industrialization Engineer Hardware

  • Permanent contract 
  • Starting date:  
  • Villejuif
  • Occasional remote authorized
  • Master's Degree
  • > 3 years

The company

Stilla Technologies

Stilla Technologies

  • Health, Pharmaceutical / Biotech
  • From 50 to 250 employees

The job

Industrialization Engineer Hardware

  • Permanent contract 
  • Villejuif

About

Stilla Technologies is a Life sciences company whose mission is to improve health by offering researchers and clinicians worldwide solutions for high precision genetic analysis.

Since 2016, Stilla Technologies has empowered researchers with the Naica System, a solution that enables to detect & quantify DNA with unprecedented precision.

The Naica System supports a wide range of genetic tests and molecular biology assays — including liquid biopsy tests for cancer diagnostics, viral load quantification, pre‐natal testing, and GMO detection. Overall, the Naica System’s superior performances make it a preferred technology for precision medicine research and therapeutic monitoring.

Stilla advises and supports its customers worldwide with a multidisciplinary team, whose expertise spans from microfluidics and chemistry, to molecular biology and computer science.

Job description

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

Preferred experience

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

Meet the Stilla Technologies team

Stilla Technologies

Stilla Technologies

Industrialization Engineer Hardware

  • Permanent contract 
  • Starting date:  
  • Villejuif
  • Occasional remote authorized
  • Master's Degree
  • > 3 years
Questions and answers about the offer
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