Shwetha Mahadevappa
Phoenix
Summary
Result oriented Engineer with 9 years of experience spanning aerospace, automotive, teaching and MedTech industries. Special interest in developing technical strategies & competencies with the intent of process improvement & delivering good quality work.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Quality Engineer
Becton Dickinson
Tempe
09.2024 - Current
- Becton Dickinson is a global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents.
R&D Engineer 2
Becton Dickinson
Tempe
03.2023 - 09.2024
- Supported three distinct businesses within the organization, demonstrating versatility and adaptability in my role.
- Serve as a key Risk Management Engineer ensuring safety and regulatory compliance across BD's global device portfolio by leading ISO 14971-driven risk assessments and mitigation activities spanning mechanical, electrical, software, cybersecurity, and usability risks, influencing products used by millions of patients worldwide.
- Strengthen patient safety and prevent regulatory gaps by driving risk controls and verification activities that reduce hazard-related defects by up to 30%, support successful audits, and help avoid costly recalls.
- Led enterprise remediation of 1,000+ hazard line items across multiple dispensing platforms following FDA Warning Letter, restoring compliance and preventing >$2B in potential business impact.
- Built a unified, scalable SHA/HHA/BRA/RMR framework, reducing document complexity and review cycles by 20%, and enhancing methodologies for greater efficiency and compliance.
- Directed high-stakes Situation Analyses, leading cross-functional teams to execute rapid containment, severity-driven risk assessments, and field actions that protected thousands of devices in clinical use.
- Developed and optimized test fixtures that improved data accuracy and validation efficiency, enabling successful material qualifications and safeguarding over $29M in annual revenue across critical oncology and infusion product lines.
- Served as a global R&D SME for Project Pioneer, a strategic initiative launching a breast biopsy product and shifting manufacturing to China, a market that represents 53% of our total probe business.
- Becton Dickinson is a global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents.
Senior Design Engineer
Becton Dickinson
Bangalore
12.2022 - 03.2023
- Becton Dickinson is a global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents.
Design Engineer
Becton Dickinson
Bangalore
03.2020 - 12.2022
- Becton Dickinson is a global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents.
Freelance Tutor
Wyzant
USA
02.2017 - 12.2017
- Tutored students with Mechanical subjects starting from fundamentals to advanced topics, resulting in significant improvements in their understanding and performance.
Engineer
Indian Institute of Science
Bangalore
09.2016 - 01.2017
- Performed functional simulation of automobile parts such as Accelerator pedal, Adapter and Bayonet connecter.
- Offered major contribution for the optimization of the design with increase in its force withstanding capability by 20% and reduction in its weight by 10%.
Project Associate
Indian Institute of Science
Bangalore
07.2016 - 08.2016
Project Intern
Indian Institute of Science
Bangalore
06.2015 - 07.2016
- Designed a Kevlar-based fan blade containment system for an aircraft gas turbine engine which was 30% more weight-efficient than the conventional metals such as steel, titanium, and aluminium.
CAE Analyst
Robert Bosch Engineering
India
Education
Masters - Materials & Systems Eng. Design
National Institute of Technology
Warangal01.2016
Bachelors - Aeronautical Engineering
Visvesvaraya Technological University
01.2012
Certification
- Dale Carnegie Training India, 2021
- Design for Six Sigma Foundation Course, 2021
- Solidworks Basics and Advanced, 2020
- Diploma in Computer Aided Engineering, 2016
- Design Control and Risk Management, 2025
- Risk Management for Medical Devices, 2025
Accomplishments
- SPOT Award, 2022, Noteworthy contributions towards WIN Excellence Award
- Pat on back award, 2022, Project milestone execution & reducing the project timeline by 40%
- Technical Excellence award, 2021, Noteworthy contribution towards Test method development
- Society of Women Engineers FY24 Patent Recognition Award, 2024
- Quality Impact Award, 2025, Demonstrating strong team values by supporting team members
- SPOT Award, 2025, Leading the remediation effort related to FDA Warning letter
Patents
- US20240085857A1, Single use disposable elapsed time indicator with volatile fluid
- US20230166025A1, Single use disposable time indication devices
- US20240094679A1, Single use disposable elapsed time indicator with absorbable material
- U.S. Patent Appl. No. 19/202,397, Closed-System Drug Transfer Devices With Controlled Connect and Disconnect Features
- US20250332356A1, Locking Connection for Syringe Adapter
Timeline
Senior Quality Engineer
Becton Dickinson
09.2024 - Current
R&D Engineer 2
Becton Dickinson
03.2023 - 09.2024
Senior Design Engineer
Becton Dickinson
12.2022 - 03.2023
Design Engineer
Becton Dickinson
03.2020 - 12.2022
Freelance Tutor
Wyzant
02.2017 - 12.2017
Engineer
Indian Institute of Science
09.2016 - 01.2017
Project Associate
Indian Institute of Science
07.2016 - 08.2016
Project Intern
Indian Institute of Science
06.2015 - 07.2016
CAE Analyst
Robert Bosch Engineering
Masters - Materials & Systems Eng. Design
National Institute of Technology
Bachelors - Aeronautical Engineering
Visvesvaraya Technological University