Advanced Manufacturing Engineer

Advanced Manufacturing Engineer

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Drive product quality improvements through systematic problem solving.

• Lead design requirements for manufacturing processes, tools, and fixtures.

• Design and manufacture jigs, fixtures, and tooling (internal or supplier-managed).

• 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.

• ECO coordination and controlled release management.

• Strong understanding of compliance, EHS, and regulated manufacturing.

• Ability to train and qualify production and supplier teams.

• Mechanical/electromechanical assembly expertise.

• Experience with HV/LV wiring, detector systems, and motion integration.

• Strong analytical and RCA skills (8D, 5-Why).

• Comply with the GE HealthCare Quality Manual, QMS, Quality Goals, and all applicable regulations.

• Complete all required Quality & Compliance training within deadlines.

• Report quality or compliance concerns immediately and support corrective action.

• Strong understanding of document control, design transfer, verification, validation, acceptance activities, DMR/DHR, and electronic signature requirements.