Siva Rangaraj

Accomplished Mechanical Engineer with extensive experience at Baxter Healthcare, specializing in risk management and compliance. Proven track record in leading design change assessments and optimizing processes, resulting in significant cost savings. Skilled in DFMEA and cross-functional team coordination, ensuring regulatory adherence and successful project outcomes.

12/25

18+ years of experience in Product and System Design, Risk Management, and Compliance, specializing in the Medical, Automotive, and Industrial sectors. Over the past 10 years at HCL Technologies, I have led medical product design and development, systems engineering, and project management, ensuring regulatory compliance and risk mitigation for highly regulated medical devices., Extensive experience in dFMEA, pFMEA, uFMEA, and Service FMEA, ensuring product safety, reliability, and compliance with industry regulations. Proficient in risk assessments, mitigation strategies, and impact analysis for medical devices and disposable products., Expertise in developing and managing Design Inputs, Requirements Traceability Matrices (RTM), and Design Outputs, including drawings, BOMs, 3D models, and work procedures. Strong ability to analyze, document, and remediate design requirements to align with FDA, ISO, and IVDR regulations., Proficient in gap analysis, test protocol development, and laboratory testing to validate product performance. Experienced in conducting verification studies on diagnostic instruments and preparing comprehensive technical reports based on laboratory test results., Skilled in managing requirement modifications and coordinating with cross-functional teams to assess and implement changes in a controlled and structured manner. Strong ability to identify and resolve risk-related gaps in design and manufacturing processes while ensuring minimal project disruption., dFMEA, pFMEA, uFMEA, Service FMEA, DOORS, Azure DevOps, Creo, Windchill, SolidWorks, Agile PLM, TcU, Agile, Lean Six Sigma, Regulatory Compliance (FDA, ISO, IVDR)

• Received momento for Idea generation in GE Healthcare
• Received appreciation comment from my GE manager for my 1.2Million saving on new proposal design in Linkedin profile.