Joshua Schaefer
Director of Manufacturing at Cranius Therapeutics
Based in Frederick, United States
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Seniority
Director
Department
Manufacturing & Production
Location
Frederick
Industry
Medical Equipment Manufacturing
Company size
16
Contact information
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j•••••••@craniusmed.com
Phone
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Background
About Joshua Schaefer
Technical Leader & Innovator with over 15 years of experience in product development and operations. Problem solving and technical management that lead to patient and business driven solutions. Helped launch Eversense CGM, the first and only long-term continuous glucose monitoring system. Lead product development and managed the process development, manufacturing and supply chain for the product. Also designed a custom dashboard for connecting product performance & manufacturing data that was leveraged for root cause analysis and continuous improvement. Expertise includes: Class Implantable Medical Devices Combination Devices (Fill/Finish and Assemble/Pack/Label) Data Management (UX and UI Design) System Level Root Cause Analysis and Product Monitoring Design Transfer (DFM, GMP) Managing Clinical and Commercial CMOs Process Verification and Validation (IQ, OQ, PQ) Equipment Acquisition and Qualification Quality and Regulatory (ISO 9001: 13485, SOP, DHF, dFMEA, pFMEA, CAPA, UID) Microelectronic-Assembly (SMD, Wirebonding, Flip-Chip Attach [Thermocompression/Ultrasonic]) Wafer Fab and Assembly (Design, Backlapping, CMP, Thin Film Filter Coating, UBM, Component attach) Optical System Design (Antennas, Circuit Boards, LEDs, Photodiodes and Filters) ERP/MRP Systems Operations Finance
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