Diraviam Thirugnanam

About Diraviam Thirugnanam

Results-oriented Technology Leader with proven success in strategic technology management, quality assurance and regulatory affairs and program management based on over 30 years of experience in competitive medical device industry. Solid history of accomplishments in controlling overall facets of quality and regulatory compliance regarding medical device software, electro-mechanical, and engineered medical devices. Demonstrated expertise in establishing/sustaining quality management system in compliance with ISO13485 standard, FDA Quality System Regulations (21CFR820) and regulatory compliance, manufacturing quality, post market compliance, development, and execution, and change management. Proven expertise in design, development, and manufacturing of In-Vitro Diagnostics Devices, Planning/targeting Solutions for Image-Guided Interventional Oncology procedures, Surgical C-Arm, and Ultrasound products from concept to production for global markets including securing country specific regulatory approvals. AREAS OF EXPERTISE• Quality Assurance & Regulatory Affairs Management• Pre-market, Post-market Regulatory Compliance• Software as a Medical Device (SaMD) Regulatory Pathway• Medical Device Risk Management • ISO 13485, FDA QSR based Quality Management Systems• Auditing QMS - ISO 13485:2016 Lead Auditor• Good Manufacturing Practices (GMP)• Product Remediation / Recalls Management• Product Cost Productivity / Vitality Management• Product Life Cycle Management • Strategic Business Planning• Cross Functional Leadership • Hiring, Performance Management

Experience

1. Director Remediation

   Getinge

   Mar 2024 — Present · Wayne, NJ, US

   Starting new position in Getinge.

Education

• Birla Institute of Technology and Science, Pilani

  B.E., Electrical & Electronics Engineering

  1984 — 1988

• The George Washington University

  Master of Science in Health Sciences, Regulatory Affairs

  2016 — 2018

Skills

• Product Development
• Analysis
• Dmaic
• Leadership
• R&D
• Iso 13485
• Design Control
• Functional Management
• Program Management
• Dicom
• Product Management
• Quality Assurance
• Design for Manufacturing
• Manufacturing
• Product Life Cycle Management
• Fda
• Product Remediation
• U.s. Food and Drug Administration (Fda)
• Product Design
• Six Sigma
• Product Launch
• Medical Devices
• Lean Manufacturing
• Process Engineering
• Testing
• Research and Development (R&D)
• Continuous Improvement
• Engineering Management
• Medical Imaging
• Project Planning
• Management
• Engineering
• Cross-Functional Team Leadership
• New Vendor Development
• Quality System
• Product Lifecycle Management
• Integration
• Quality Management