MEHUL GURJAR
Monroe Township,USA
Summary
Biomedical Engineer and Subject Matter Expert with over 5 years of industry experience at global leaders Getinge and Medtronic. Specialist in the verification and validation (V&V) of life-critical medical systems, including Surgical Robotics and Intra-Aortic Balloon Pumps (IABP). Expert in navigating complex international regulatory standards (IEC 60601, ISO 10993, UL 2900) to secure 510(k) and TUV compliance. Proven track record in technical synthesis, mentorship, and 'technical-to-layman' translation for cross-functional teams and AI research applications.
Overview
5
5
years of professional experience
Work History
Biomedical Engineer
Getinge
Wayne, USA
05.2025 - Current
- Developed and executed test protocols for Cardiosave IABP, ensuring compliance with FDA 510(k) and TUV SUD (EU MDR) standards.
- Multi-Domain Validation: Manage V&V activities across Electromagnetic Immunity (EMC), Cybersecurity (ANSI/UL 2900), and Biocompatibility.
- Regulatory Logic: Conduct Gap Analysis and FMEA to ensure compliance with IEC 60601-1-8 and IEC 60601-2-34.
- Collaborated with Regulatory and QA teams to validate test results and document safety rationales for life-critical cardiac equipment.
Biomedical Engineer
Medtronic
North Haven, USA
05.2017 - 11.2021
- Robotics Diagnostics: Identified and resolved critical mechanical, electrical, and software integration failures for a flagship surgical robotic platform.
- Software-in-the-loop (SIL): Debugged Linux-based code for automated software testing of hardware sensors and logic synchronization.
- Data Synthesis: Used Minitab for advanced statistical trend analysis and prototype optimization.
- Technical Translation: Communicated complex failure data into actionable insights for Marketing and Product teams.
- Technical Mentorship: Designed and delivered training on GDP, compliance workflows, and diagnostic logic for new engineering hires.
Research Assistant
Medtronic
North Haven, USA
09.2015 - 05.2016
- Developed and optimized novel laparoscopic tool in SOLIDWORKS for liquid adhesive application, overseeing project from conception to final expo.
Education
Bachelor of Science (B.S.) - Biomedical Engineering
University of Hartford
West Hartford, CTSkills
- Python
- Java
- SQL
- HTML/CSS
- OutSystems
- Linux
- SOLIDWORKS
- AutoCAD
- CREO
- MATLAB
- LabVIEW
- Minitab
- AGILE
- Jama
- JIRA
- SharePoint
- Test protocol development
- Data analysis
- Cross-functional collaboration
- Technical mentorship
- Attention to detail
Core Subject Matter Expertise
- Regulatory & Standards Mastery, Expert-level knowledge of FDA 510(k) and T
- V (EU MDR) pathways; mastery of IEC 60601-1 (Safety), 1-2 (EMC), 1-8 (Alarms), and 1-12 (EMS Environment).
- V&V Strategy, Extensive experience writing and executing IQ/OQ/PQ protocols, software validation, and performance qualification for Class II and III devices.
- Specialized Domains, Biocompatibility (ISO 10993), Medical Device Cybersecurity (UL 2900), Usability/Human Factors (IEC 62366), and Cleaning/Disinfection (TIR12).
- Systems Engineering, Diagnosis of complex mechanical/electrical/software failures in robotics; expert in statistical trend analysis (Minitab) and Root Cause Analysis.
Publications
'Nonequilibrium Atmospheric Pressure Dielectric Barrier Discharge in Ophthalmology', Plasma Medicine, Researched plasma-induced apoptosis for oncology applications.
Timeline
Biomedical Engineer
Getinge
05.2025 - Current
Biomedical Engineer
Medtronic
05.2017 - 11.2021
Research Assistant
Medtronic
09.2015 - 05.2016
Bachelor of Science (B.S.) - Biomedical Engineering
University of Hartford