Ingénieur Industrialisation Expert F/H
Core
Define, design, and implement manufacturing processes for medical devices, ensuring compliance with GMP/BPF standards during the transition from R&D to production.
Role type
Manufacturing Process Engineer (Medical Devices)
Builds
Medical device manufacturing infrastructure and processes
Domain
Medical Devices / Manufacturing Engineering
Required skills
Project management, Process validation (QI, QO, QP), Statistical methods (ISO 2859), Lean manufacturing, Value stream mapping, Risk analysis (ISO 14971, FMEA), Industrial finance, Material properties (polymers, stainless steel, nitinol), Mechanical and electronic assemblies
Preferred skills
FDA 21CFR820.40 (DMR), MDR/ISO 13485 regulations, English (fluent), Higher education in Mechanical/Industrial Engineering/Physics/Automation
Technologies
ISO 13485, ISO 14971, ISO 2859, FDA 21CFR820.40, FMEA, Lean
Responsibilities
Develop efficient manufacturing plans in a lean spirit; Define manufacturing requirements during product design; Improve processes and design new equipment/procedures; Write user requirement specifications; Establish production process specifications; Implement process monitoring and stability plans; Coordinate equipment purchase, installation, and qualification; Ensure equipment availability and reliability; Create and update Device Master Record (DMR); Analyze manufacturing risks (PFMEA); Select and qualify suppliers; Execute pilot batches.
Seniority
Mid-Senior, hands-on IC