I am an Engineering leader with 15+ years of experience working with teams to design, launch, and manufacture Medical Devices in compliance with 21CFR820, cGMPs, and ISO13485 standards. My areas of expertise include process validation, new product introduction, and continuous improvement projects in the medical device industry.Throughout my career, I've consistently driven innovation, improved processes, and reduced costs while ensuring compliance with regulatory requirements. I'm passionate about leveraging my technical knowledge and leadership skills to drive excellence in medical device manufacturing and process validationKey Highlights:🔹 Bachelor’s degree in electrical engineering (BSEE)🔹 Extensive knowledge of FDA regulations, cGMP, and ISO13485🔹 Strong background in statistics, data analysis, and Design of Experiments (DOE)🔹 Proficient in Minitab, JMP, and SolidWorks🔹 Lean Six Sigma Black Belt with a focus on DMAIC methodology🔹 Experienced in leading cross-functional teams and managing complex projects🔹 Expertise in process validation (IQ/OQ/PQ) and risk analysis (PFMEA, DFMEA, UFMEA)Core Competencies:🔹 New Product Introduction (NPI) and Design Transfer🔹 Process Improvement and Cost Reduction🔹 Statistical Process Control (SPC) and Process Capability Analysis🔹 Design for Manufacturability (DFM)🔹 Root Cause Analysis and Problem-Solving Techniques🔹 Technical Writing and Documentation🔹 Vendor and Supplier Management🔹 Continuous Improvement (Kaizen, Process Excellence)