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Advanced Manufacturing Engineer - PET & SPECT Imaging

gehc · Haifa

جديد
Senior 🇬🇧 English
PFMEA LEAN 8D ISO 13485 ISO 14971 21 CFR 820 IEC 60601 IQ/OQ/PQ DFM/DFA

وصف الوظيفة

About the role

The Advanced Manufacturing Engineer (AME) at GE HealthCare in Haifa is responsible for industrializing and sustaining complex PET and SPECT imaging products at a high-complexity electromechanical manufacturing site. The role covers robust manufacturability of mechanical assemblies, electronics integration, wiring, detector modules, motion systems and system-level testing, and drives process development, tooling, validation, DFM/DFA, quality improvement and NPI readiness.

Key responsibilities

  • NPI leadership: lead manufacturing readiness for new PET/SPECT products, including process layout, tooling development and new equipment introduction, and coordinate ECO implementation
  • Process development: develop assembly processes for mechanical and electronic integration, alignment, torque control and detector installation, and design jigs, tools, fixtures and handling solutions
  • Drive LEAN manufacturing, continuous improvement and PFMEA for existing and new processes
  • Quality and problem solving: work with production associates to resolve manufacturing and quality issues, oversee corrective actions and support RCA
  • System integration and testing support: support calibration, alignment, motion validation, detector gain calibration and safety checks, and work with System Engineering on test protocols
  • Validation and regulatory compliance: own IQ/OQ/PQ, ensure compliance with ISO 13485, ISO 14971, 21 CFR 820, IEC 60601 and internal QMS, and maintain control plans, validation protocols and DHR/DMR accuracy
  • Supplier collaboration: lead technical discussions with suppliers on tooling, process capability and quality, and train and qualify production and supplier teams
  • EHS and plant compliance: lead and support EHS efforts and safe handling of large assemblies, HV systems and radiation-related components

Required profile

  • Strong experience with LEAN manufacturing and PFMEA execution
  • Ability to resolve complex manufacturing and quality issues and lead NPI activities including tool development and equipment introduction
  • Mechanical/electromechanical assembly expertise, with experience in HV/LV wiring, detector systems and motion integration
  • Strong analytical and RCA skills (8D, 5-Why)
  • Ability to train and qualify production and supplier teams

Required skills

  • LEAN manufacturing and PFMEA
  • IQ/OQ/PQ validation and ISO 13485, ISO 14971, 21 CFR 820, IEC 60601 compliance
  • Document control, design transfer, verification and validation, DMR/DHR and electronic signatures
  • 8D and 5-Why root cause analysis

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gehc

Haifa