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Advanced Manufacturing Engineer
·Israel
On-siteFull-timeHardware EngineeringMedTech
Responsible for industrializing and sustaining complex PET and SPECT imaging products at a high-complexity electromechanical manufacturing site. Drives process development, tooling, validation, DFM/DFA, quality improvement, and production readiness for new product introductions.
Responsibilities
- Lead manufacturing readiness for new PET/SPECT products, including process layout, tooling development, and new equipment introduction.
- Participate in design reviews and influence DFM/DFA/DFT across mechanical assemblies, detector modules, and electromechanical subsystems.
- Develop robust assembly processes for mechanical and electronic integration, alignment, and detector installation.
- Define and design manufacturing jigs, tools, fixtures, and lifting/handling solutions.
- Drive product quality improvements by identifying manufacturing issues and implementing cost-effective solutions.
- Own IQ/OQ/PQ for equipment, tools, and manufacturing processes, ensuring compliance with ISO 13485, ISO 14971, 21 CFR 820, and IEC 60601.
- Collaborate with suppliers of mechanical assemblies, detector modules, wiring harnesses, and PCBs.
Requirements
- Strong experience with LEAN manufacturing and PFMEA execution.
- Ability to resolve complex manufacturing and quality issues.
- Leadership of NPI activities including tool development and equipment introduction.
- Mechanical/electromechanical assembly expertise.
- Experience with HV/LV wiring, detector systems, and motion integration.
- Strong analytical and RCA skills (8D, 5-Why).
- Understanding of document control, design transfer, verification, validation, and regulatory compliance.