Summary
Overview
Work History
Education
Skills
Research
Certification
Timeline
Generic

Murali Krishna

Denton

Summary

Quality Engineer with significant years of experience in the medical device industry, specializing in New Product Development, CAPA, Risk Management, and QMS compliance with FDA 21 CFR Part 820, ISO 80369-7, ISO 594 and ISO 13485. Skilled in statistical analysis using Minitab, design verification and validation (V&V), and CAD tools. Proven ability to work independently, lead initiatives, and contribute to cross-functional teams.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Quality Engineer

Fission Inc.
02.2025 - 06.2025
  • Developed, implemented, and maintained Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory standards for medical device manufacturing.
  • Conducted risk assessments, Failure Mode and Effects Analysis (FMEA), and Design Verification & Validation (V&V) protocols.
  • Supported in creating and maintaining the Design History File (DHF), ensuring all required documentation, such as design inputs, outputs, design reviews, and risk management reports, were accurate and compliant.
  • Facilitated the review and approval process for design documentation, ensuring full traceability from design inputs to final device release.
  • Ensured proper document control for design changes and revisions, maintaining compliance with FDA and ISO regulations.
  • Supported Health Hazard Evaluation (HHE) activities for design-related risks identified during design verification and validation, ensuring early detection and proactive mitigation of patient safety concerns.
  • Conducted research to support design improvements for new medical device products, utilizing scientific literature and industry best practices.
  • Supported the planning, execution, and reporting of product testing, including bench testing and stability studies, to ensure compliance with industry standards.

Quality Engineer

Argon Medical
04.2024 - 01.2025
  • Company Overview: TX
  • Played a crucial role in the Non-Conformance Management process, including the MRB meetings, proper NCR reporting, management, and closure, issuing Corrective Actions, etc.
  • Supported the CAPA process, driving the review meetings and ensured all CARs are addressed by their respective owners in a timely manner, assisting with Root Cause investigation and CA plans.
  • Utilized trend and complaint data to identify potential systemic product issues, triggering HHE initiation and cross-functional team reviews.
  • Identified and developed the necessary process controls, along with the required data collection and management process.
  • Participated in internal audits, supported CAPA follow-through, and maintained documentation readiness for regulatory inspections.
  • Supported the Quality Management System, including developing and maintaining company documents, work instructions, etc.
  • Reviewed engineering prints and specifications for improvement.
  • Ensured all post-market investigations and reporting activities were compliant with 21 CFR 820, ISO 13485 and ISO 14971.
  • Worked with Customer Service to monitor customer complaints and managed the RMA (Return Merchandise Authorization) process.
  • Worked with the Quality Engineering Technicians and supervised the testing process when required.
  • TX

R&D Engineer

Baxter
Round Lake
11.2022 - 12.2023
  • Company Overview: Round Lake, IL
  • Evaluated Product drawings and classified products in medical devices by employing GD&T.
  • Demonstrated working knowledge of medical devices in accordance with the industry standards.
  • Worked on the Change Control activities which involves changes related to design of the products (Class II medical devices).
  • Reviewed/approved protocols, reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files.
  • Utilized Risk analysis methods such as Pareto analysis, Fishbone diagram, PFMEA and FMEA to find the cause of failure and non-conformance.
  • Acted as a Study Director and helped in issuing documents in the Quality Management Software.
  • Responsible for authoring Design control documentation including design requirements, trace matrices, risk management documents, protocols, DHF, test method instructions, and standard operating procedures.
  • Participated in signal evaluation reports, MDRs, and internal investigation summaries in alignment with FDA, EU MDR, and ISO requirements.
  • Ensured traceability of complaint investigations to signal evaluation outcomes and HHE risk classification, maintaining documentation integrity within QMS tools.
  • Worked on DHF activities such as document updates, conducting design reviews and updating DHF Index according to the protocols present in the Quality Management Software.
  • Worked on ISO Luer projects which involves the change of compliance of medical devices from ISO 594 to ISO 80369-7.
  • Performed functional testing and Shelf-Life testing on components with the assistance of Lab technicians.
  • Partnered with cross-functional teams across engineering, regulatory and manufacturing to support complaint investigations and CAPA resolution.
  • Worked on Statistical tools such as Minitab to analyze the data.
  • Round Lake, IL

Education

Master of Science - Mechanical Engineering

Wichita State University
Wichita, KS
07.2022

Bachelor of Science - Mechanical Engineering

B.V. Raju Institute of Technology
Hyderabad, India
06.2019

Skills

  • FDA 21 CFR 820
  • ISO 13485
  • ISO 9001
  • ISO 80369-7
  • ISO 14971
  • Minitab
  • TrackWise
  • SolidWorks
  • CATIA
  • AutoCAD
  • ANSYS FLUENT
  • FMEA
  • 8D
  • CAPA
  • Functional Testing
  • Shelf-Life Testing
  • Stability Studies

Research

  • FIBER REINFORCED CARBON-CARBON COMPOSITES FOR ENHANCED FIRE RETARDANCY AND ELECTRICAL AND THERMAL CONDUCTIVITIES, 05/2022, Developed a novel methodology achieving superior flame retardancy, high electrical conductivity, and thermal conductivity for structurally demanding applications, while ensuring cost competitiveness. Fabricated and assessed a carbon-carbon composite using Polyacrylonitrile (PAN) as epoxy without the reliance on hardeners or additives. Analyzed the microstructure of the carbon-carbon composite through precise SEM imaging.
  • ENHANCEMENT OF HEAT TRANSFER IN MICROCHANNEL HEAT TRANSFER USING NANOFLUIDS AND PCM SUSPENSIONS FOR COOLING, 08/2019 - 12/2019, Conducted numerical study on microchannel heat exchanger for electronic device cooling via forced convection. Designed rectangular microchannel with specific dimensions; utilized Al2O3-water nanofluid and PCM suspension flow properties using ANSYS FLUENT.

Certification

  • Lean Six Sigma White belt
  • Lean Six Sigma Yellow belt

Timeline

Quality Engineer

Fission Inc.
02.2025 - 06.2025

Quality Engineer

Argon Medical
04.2024 - 01.2025

R&D Engineer

Baxter
11.2022 - 12.2023

Master of Science - Mechanical Engineering

Wichita State University

Bachelor of Science - Mechanical Engineering

B.V. Raju Institute of Technology

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Murali Krishna