Industrialization & Manufacturing Engineer - Affluent Medical

Industrialization & Manufacturing Engineer

He/she defines and implements manufacturing processes in compliance with Good Manufacturing Practices for medical devices.


Relation hiérarchiques et fonctionnelles

N+1: Industrialization Director

Exchanging information with the Program Director (notably formalization of product design input data).

Exchanging information with Validation, Quality, R&D and Regulatory Affairs teams.

Supporting project deployment with suppliers and subcontractors.

Principales activités
  • Design and improve robust manufacturing processes in Lean Manufacturing spirit.
  • Provide the R&D product specifications taking account of manufacturing constraints.
  • Write procedures, work instructions and all required documentation to implement an efficient production flow.
  • Define user requirements specifications for new production resources investments.
  • Define and write specifications for production and control equipment.
  • Monitor investments, installation and qualification of production means.
  • Contribute to the risk analysis of manufacturing processes (internal and external in cooperation with suppliers).
  • Participate in the selection, qualification, and periodic assessment of suppliers and subcontractors.

He/She is responsible for implementing the in-house manufacturing processes as well as outsourced manufacturing processes in collaboration with suppliers.

Key player in writing and maintaining the DMR (Device Master Record – ref. FDA 21CFR820.40), in line with the person in charge of the DHF (Sr. Mgr. R&D) and the DHR (Mgr. Production & Quality) processes.

Maintain technical documentation up to date, monitor the efficiency of production processes, train users, and manage/maintain in-house equipment.

Monitor measuring equipment (calibration, documentation, etc.)


Schedules the activities according to the priorities defined by the manager.

  • A Bachelor’s / Master’s degree in Method engineering, Mechanical Engineering, Biomedical Engineering, or a related field.Project management skills
  • Understanding the concept of regulations and standards applicable to DM (MDR, ISO 13485, FDA, etc.)
  • English (read, written and spoken)
  • Operational knowledge on lean manufacturing methods
  • Operational knowledge on continuous improvement methods
  • Basic Knowledge of product costing
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