Raviteja B.

About Raviteja B.

With over 9 years of experience driving quality excellence in the medical device industry, I specialize in ensuring compliance, safety, and innovation across various medical devices. My technical foundation—a B.Tech. and M.S. in Biomedical Engineering—fuels my ability to bridge regulatory requirements with engineering rigor.Core Achievements- Spearheaded quality engineering efforts for a novel Radial to Peripheral Support Catheter, navigating end-to-end design controls, securing FDA 510(k) clearance, and guiding commercialization- Led cross-functional risk management initiatives to enhance safety profiles of legacy products, and post-market complaints backlog reduction- Certified ISO 13485:2016 Lead Auditor and Certified Lean Six Sigma Black Belt with hands-on expertise in design verification/validation, post-market surveillance, and CAPA processes to mitigate systemic quality gaps.Technical Pillars- Design Controls: Proven track record in translating user needs into V&V strategies for Class devices- Regulatory Navigation: Deep familiarity with FDA 21 CFR Part 820, EU MDR, and risk management per ISO 14971- Collaborative Leadership: Partner with R&D, manufacturing, and regulatory teams to embed quality-by-design principles.Industry Impact:I have a proven track record of improving and optimizing quality systems and products. My career spans diverse therapeutic areas—orthopedics, vascular intervention, and critical care—allowing me to adapt quality frameworks to unique clinical and technical challenges. I excel at solving complex problems at the intersection of patient safety, regulatory compliance, and scalable production. Utilizing my skill set, I have developed and implemented several cost-effective and technically sound solutions to streamline QMS processes, ensuring high standards and regulatory compliance.Expertise in Medical Device Quality, Design Controls, Risk Management, ISO 13485, ISO 14971, 21 CFR, EU MDR, FDA 510(k), Design Verification/Validation, Test Method Development/Validation, CAPA, DMAIC, DMADV, Root Cause Analysis, Device Failure Investigations, Internal and External Audits, Lean Six Sigma, Post Market Surveillance, and Regulatory Responses.

Experience

1. Npd Quality Engineer Ii

   Terumo Medical Corporation

   Apr 2022 — Present · Elkton, MD, US

   Design Assurance for new product development projects and existing commercial products at Terumo Interventional Systems.Working primarily with Access Portfolio (R2P -\"Radial to Peripheral\").

Education

• National Institute of Technology Rourkela

  Bachelor of Technology, Biomedical Engineering

• Arizona State University

  Master of Science, Biomedical Engineering

• Harrisburg University of Science and Technology

  Master Certificate, Project Management

Skills

• Matlab
• Medical Devices
• Ni Multisim
• Etq Reliance
• Biomedical Engineering
• Iso 13485
• Python
• C
• Programming
• Microsoft Office
• Risk Management
• Teamcenter
• U.s. Title 21 Cfr Part 11 Regulation
• Opencv
• Team Leadership
• Technical Leadership
• Design Failure Mode and Effect Analysis (Dfmea)
• Tecplot
• Product Complaints
• Labview
• Autocad
• Ansys
• Corrective and Preventive Action (Capa)
• Research
• Geometric Dimensioning & Tolerancing
• C++
• Complaint Management
• Tolerance Analysis
• Algorithms
• Image Processing
• Biomaterials
• Iso 14971
• Computer Vision
• Mdr
• Design Control