NPI Leadership for PET & SPECT Imaging Systems
• 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, power systems, wiring harnesses, and electromechanical subsystems.
• Translate design intent into controlled, stable manufacturing processes.
• Coordinate ECO implementation and ensure smooth manufacturing release.
Assembly Process Development & Optimization
• Develop robust assembly processes for mechanical and electronic integration, alignment, torque control, and detector installation.
• Define and design manufacturing jigs, tools, fixtures, and lifting/handling solutions required for large subsystems.
• Lead design/manufacture of equipment, tooling, and jigs internally or via suppliers to eliminate defects.
• Drive LEAN manufacturing implementation and support continuous improvement.
• Conduct PFMEA for existing and new processes.
Quality & Problem Solving
• Drive product quality improvements by identifying manufacturing issues and implementing cost‑effective solutions.
• Work with Production Associates to resolve manufacturing and quality problems.
• Oversee corrective action implementation in production or suppliers.
• Support RCA through structured failure analysis.
System Integration & Testing Support
• Support integration/testing of assembled PET/SPECT systems including calibration, alignment, motion validation, detector gain calibration, and safety checks.
• Work with System Engineering to define test protocols and acceptance criteria.
• Troubleshoot system issues related to electromechanical assemblies.
Validation & Regulatory Compliance
• Own IQ/OQ/PQ for equipment, tools, and manufacturing processes.
• Ensure compliance with ISO 13485, ISO 14971, 21 CFR 820, IEC 60601, and internal QMS requirements.
• Maintain strong documentation practices including control plans, validation protocols, and DHR/DMR accuracy.
• Ensure traceability for critical parameters, torques, and calibration data.
Supplier & Cross‑Functional Collaboration
• Collaborate with suppliers of mechanical assemblies, detector modules, wiring harnesses, and PCBs.
• Lead technical discussions with suppliers for tooling, process capability, and quality issues.
• Train and qualify production and supplier teams on processes and inspection/assembly methods.
• Lead and support Environment, Health & Safety efforts aligned with site goals.
• Ensure safe handling of large assemblies, HV systems, and radiation‑related components.