Required Advanced Manufacturing Engineer
Role Summary
The Advanced Manufacturing Engineer (AME) is responsible for industrializing and sustaining complex PET and SPECT imaging products at a high‑complexity electromechanical manufacturing site. The AME ensures robust manufacturability of high‑level mechanical assemblies, electronics integration, wiring, detector modules, motion systems, and system‑level testing. The role drives process development, tooling, validation, DFM/DFA, quality improvement, and readiness for production and NPIs.
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.
EHS & Plant Compliance:
Lead and support Environment, Health & Safety efforts aligned with site goals.
Ensure safe handling of large assemblies, HV systems, and radiation‑related components.