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Industrialization Engineer - France  

Spine Vision (company)


Posted on : 12 April 2017

Project Description

Description : 
  • Responsible for optimization and control of industrialization process (equipment, methods…), in compliance with quality and regulatory requirements and specifications. 
  • Delivers a regular reporting. Implements preventive maintenance plans, operational methods and dysfunction indicators. 
  • Develops and validates the technical feasibility of industrial development project and process optimization. 
  • Implements and follows-up action plans. Manages process qualification (QI, QO, QP), risk analysis (ISO 14971 standards), subcontractors identification and follow-up. 
  • Develops and manages Device Master Record.

Requirements :  
  • Higher education diploma (Engineering School, Master Degree DEA or DESS), specialized in industrialization processes, mechanical, biomedical. 
  • Working experience of 3 years in the medical device industry (ideally Spine) or aeronautics industry. 
  • Confirmed operational with multiple technical skills enabling an autonomous management of the industrialization project. 
  • Pragmatic and ability for synthesizing information in order to communicate a precise and regular reporting. 
  • Fluent in English, master of MS Office suite, Solidworks, MS project and excellent knowledge of 93/42/CEE directives, ISO 13485 and ISO 14971 standards.
  •  Excellent knowledge in biochemistry (sterilization) and biology. Strong base knowledge of manufacturing process. 
  • Basic financial knowledge for budget monitoring.  Must have the ability to multi-task in order to oversee multiple projects at one time.
  •  Must be a motivated self-starter, able to work independently. Must be flexible, creative and proactive.
  •  Must have an analytical capability and ability to innovate and propose the right solutions. 
  • Must be a team player with the ability to work with staff at different organizational levels across various business units.