Advanced Manufacturing Engineer - PET & SPECT Imaging
gehc · Haifa
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