Manufacturing Processes Development, DFM, Engineering Lead

IsoRay Medical, Inc. Jun 2021 – Feb 2023

Design & Develop of Innovative Process Devices using SolidWorks, working with Machine

shops for building prototypes and production units. Lead R & D activities to define product characteristics for process design, quality control. Ensured product and system quality by providing “Engineered Process Controls & sustainability of capabilities as part of engineering technical support. The primary responsibilities were to evaluate manufacturing systems based on Class II Medical Device safety (The FDA Design Control guidance 21 CFR 820.30 & Quality Management System (QMS) Regulation under 21 CFR 820 &  ISO 13485:2016), and demanding market performance standards. Validation & verification plans & test scripts; Troubleshoot equipment; Optimized productivity; Developing innovative methods; Initiated informal ECR (Company did not have formal process) or Designs in support of DFM & DFA; Provided guidance and advice to manage quality and sustain daily operations.