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Unknown is seeking a Lead Manufacturing Engineer to own precision assembly, calibration, testing, validation, and scalable production processes for a high-rel medical device. You will partner with R&D, Quality, Operations, and suppliers to troubleshoot issues and drive yield, reliability, and process improvements across manufacturing lines.
You will guide engineers and technicians through production changes, ensure documentation and compliance, and translate prototypes into validated production.
Lead manufacturing engineering for the OTTAVA surgeon input device, developing and owning precision assembly, calibration, testing, validation, and scalable production processes. Partner with R&D, Quality, Operations, and suppliers to troubleshoot issues, improve yield and reliability, manage production changes, and guide engineers and technicians.
Requires a bachelor's degree in a relevant engineering discipline and 8-10 years of manufacturing or assembly engineering experience, including at least five years with precision electromechanical or comparable high-reliability systems. Candidates need expertise in precision mechanisms, regulated medical-device manufacturing, CAD/GDT, statistical process methods, process documentation, and taking processes from prototype through validated production.
Precision Electromechanical Assembly, Manufacturing Process Development, Medical Device NPI, Mechanical Mechanism Design, Encoder and Sensor Integration, Calibration and Verification, CAD and SolidWorks, ASME Y14.5 GD&T, Tolerance Stack-Up Analysis, Statistical Process Control, Capability Analysis, Design of Experiments, PFMEA, Root-Cause Analysis, Process Validation, Cross-Functional Leadership