Npi Manufacturing Engineer
Current✦ Mechanical Design & Documentation: Collaborated with cross-functional teams to optimize mechanical designs for surgical robotics systems using SolidWorks, with a focus on precision, manufacturability, and durability. Managed technical drawings, specifications, and BOMs using PDM systems, ensuring robust design processes and traceability.✦ Manufacturing Process Development & Compliance: Developed MPIs and TPIs to streamline manufacturing processes, using MES and DHRs to enhance operational efficiency and maintain regulatory compliance. Facilitated smooth transitions from R&D to production.✦ Systems Engineering, Programming & Integration: Defined system performance requirements (PRDOs) and programmed PCAs/HLAs using Ubuntu and custom software, leading system integration, testing, and performance validation. ✦ Risk Analysis & Quality Improvement: Conducted PFMEA and applied the 5 Whys method for root cause analysis, identifying risks and implementing corrective actions to enhance system reliability. ✦ End-to-End Product Lifecycle: Involved in the complete product lifecycle, from R&D through Verification & Validation (V&V) and regulatory submissions, ensuring comprehensive testing and compliance. ✦ Test Automation & Validation: Developed Python scripts to automate testing and improve data collection for performance evaluation. Executed IQ/OQ/PQ protocols to validate manufacturing equipment and processes, ensuring adherence to R&D and regulatory standards.