Advanced Manufacturing Engineer
Core
Industrialize and sustain 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
Senior IC Advanced Manufacturing Engineer (Medical Imaging)
Builds
Production-ready PET/SPECT imaging systems, detector modules, and electromechanical assemblies
Domain
Medical device manufacturing (PET/SPECT imaging)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LEAN manufacturing, PFMEA, DFM/DFA, IQ/OQ/PQ validation, RCA (8D/5-Why), supplier management, ECO coordination, mechanical/electromechanical assembly expertise, HV/LV wiring knowledge, motion system integration, tooling design
Preferred skills
Radiation component handling, large subsystem handling, cross-functional leadership
Technologies
PET/SPECT systems, detector modules, motion systems, wiring harnesses, PCBs
Responsibilities
Lead NPI manufacturing readiness including process layout and tooling development; Develop assembly processes for mechanical and electronic integration; Drive LEAN implementation and conduct PFMEA; Own IQ/OQ/PQ validation for equipment and processes; Ensure compliance with ISO 13485, 21 CFR 820, and IEC 60601; Collaborate with suppliers on tooling and quality issues; Support system integration and testing including calibration and safety checks.
Seniority
Senior, hands-on IC