Advanced Manufacturing Engineer
Core
Industrializing and sustaining complex PET and SPECT imaging products at a high-complexity electromechanical manufacturing site, ensuring robust manufacturability of mechanical assemblies, electronics integration, and system-level testing.
Role type
Advanced Manufacturing Engineer (NPI & Process Development)
Builds
PET/SPECT imaging systems, detector modules, motion systems, and electromechanical assemblies
Domain
Medical technology / Nuclear medicine / Electromechanical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LEAN manufacturing, PFMEA, Design for Manufacturing (DFM), Design for Assembly (DFA), Root Cause Analysis (RCA), 8D problem solving, tooling design, process validation, supplier management, regulatory compliance (ISO 13485, 21 CFR 820), mechanical/electromechanical assembly expertise, HV/LV wiring knowledge, motion system integration
Preferred skills
Experience with large subsystems handling, radiation-related component safety, electronic signature requirements, training production teams
Technologies
None explicitly listed beyond general tooling and equipment
Responsibilities
Lead manufacturing readiness for new PET/SPECT products including process layout and tooling development; Develop robust assembly processes for mechanical and electronic integration; Define and design manufacturing jigs, tools, and fixtures; Drive LEAN manufacturing implementation and continuous improvement; Conduct PFMEA for existing and new processes; Own IQ/OQ/PQ for equipment, tools, and manufacturing processes; Collaborate with suppliers for tooling and process capability; Support integration and testing of assembled systems including calibration and safety checks
Seniority
Mid-to-Senior, hands-on IC with NPI leadership responsibilities