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In-Office
Hayward, CA, USA
130K-155K Annually
Senior level
130K-155K Annually
Senior level
Healthtech • Biotech • Nanotechnology • Pharmaceutical
Leads process development and design transfer for catheter devices from early-stage configurations to commercial manufacturing. Responsibilities include DFM/DFA, tolerance analysis, catheter and electrical assembly process optimization, validation, FMEAs, SPC, measurement studies, supplier qualification, sterilization compatibility, lean improvements, ECOs, documentation, and cross-functional collaboration. Mentors junior staff and supports production readiness in a regulated medical-device environment.
Top Skills: Adhesive JoiningCadCatheter BraidingCatheter ExtrusionCleanroom Iso Class 7/8Cp/CpkDesign For AssemblyDesign For ManufacturabilityE-Beam SterilizationEcoEo SterilizationFda Qsr 21 Cfr Part 820Fine-Gauge Wire TerminationFmeaGamma SterilizationGauge R&RGd&TIq/Oq/PqIso 13485Iso 14971Laser CuttingMinitabProcess ValidationSolidworksSpcStatistical Process ControlSurface Mount TechnologyThermal BondingTip Forming
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