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INDUSTRIALIZATION ENGINEER f/m

Start of mission:
17.08.2021
Job city:
163 Avenue de Luminy, 13009 Marseille
Type of contract:
CDD

Job description

INDUSTRIALIZATION ENGINEER f/m

Fixed term contract 7 months –Marseille (FR-13009 - Luminy)

 

The Industrialization Engineer joins the "Outsourcing of Product Development for Diagnostic and Research" team. You will participate in the industrialization of medical diagnostic kits. In particular, you ensure the transfer activities of PMA, 510K, CE-IVD products designed by the development teams, your main missions will therefore be:

 

  • Plan and supervise the transfer of new products to manufacturing including specific quality control processes and stability monitoring.
  • Perform risk analyzes related to raw materials, products and their production.
  • Define, coordinate and ensure the follow-up of actions related to the transfer in compliance with regulatory, quality and safety requirements and within project deadlines.
  • In relation to the manufacturing teams, ensure production capacities upstream of the launch.
  • Guarantee the start of production by defining and optimizing the means and manufacturing processes to be used.
  • Create the documentation associated with the transfer (production, quality control and stability monitoring).
  • Be responsible for inter-service communication

 

Profile

  • Engineer (m / f) you have at least 2 years of experience in industrial transfer of medical devices.
  • You know the stages of the development and industrialization of diagnostic kits: manufacturing process, development of quality control methods (BPF / GMP), sending...
  • You have skills in molecular biology, statistics and analysis of risks.
  • Familiar with troubleshooting, you know how to use planning tools in order to meet deadlines.
  • You are familiar with GLP, ISO 9001, ISO 13485, ISO 14971, 21CFR part 820, the European Directives relating to IVD medical devices and the new European regulation.
  • You speak fluent English (oral and written is required) and ideally French.

 

What we can offer you:

Are you looking to develop new skills in a growing technology company?  We want to offer you a work environment that encourages team spirit, promotes training and offers career development opportunities, in France and internationally!