Saravanan N

WORK HISTORY

EDUCATION

ABOUT SARAVANAN N

I bring ideas to life while ensuring compliance! A dedicated Biomedical Engineer from Georgia Institute of Technology with a passion for medical device innovation, safety, and compliance. My journey in R&D, medical device design, and quality engineering has been shaped by hands-on experience in medical device development, regulatory frameworks, and industry best practices. As a problem solver and continuous learner, I strive to bridge the gap between design, quality, and compliance, ensuring that every product meets the highest standards of safety and efficacy. With expertise in ISO 13485, FDA regulations, and risk management, I am committed to driving innovation while maintaining regulatory excellence. Currently, I am exploring post-market engineering at Cook Medical, working on medical devices compliance support, verification, and validation. My goal is to lead product development teams and contribute to life-saving innovations in the healthcare industry. Specialties: Medical Device Design & Development ISO 13485 | FDA 21 CFR 820 | Risk Management Quality Assurance (QA) & Quality Control (QC) Verification & Validation (V&V) Failure Mode & Effects Analysis (FMEA) Design Control Project Management & Cross-Functional Collaboration Lean Six Sigma & Statistical Process Control 3D Modeling & CAD (SolidWorks, Creo, Fusion 360, FreeCAD) Data Analytics (Python, R, MATLAB, Tableau) Team Leadership I’m always open to connecting with professionals in medical device industry