He/she defines and implements manufacturing processes in compliance with Good Manufacturing Practices for medical devices.
DESCRIPTION DE POSTE
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.
Responsabilité
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.)
Autonomie
Schedules the activities according to the priorities defined by the manager.
COMPETENCES REQUISES
- 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