Industrialization Engineer - France
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- 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.
- 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.