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Click here or scroll down to respond to this candidate Candidate's Name
Atlanta, GA
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PROFESSIONAL BIO
Solution and Systems Engineer with 9 years of experience in medical and electrical device design and lifecycle management.
- At Siemens, my role as a Solutions and Systems Engineer centers around ensuring the functional safety, reliability, and
security of EMobility solutions.
- Leveraging UL, IEC, ISO and NIST Frameworks - successfully launched DER products and medical devices
- Integration of risk analysis, interoperability improvements, and customer-centric product development to achieve the best
quality medical and electrical solutions.
- Certified Product and Solution Security Engineer
PROFESSIONAL EXPERIENCE
Solutions and Systems Engineer, Siemens (EV Chargers), Peachtree Corners, GA May 2023 Present (July 2024)
Launched and achieved NTEP, UL certifications for DER (Distributed Energy Resource) products as a Product
and Solution Security Specialist
Design safety and safety architecture solutions for low power charger products using tools like Threat & Risk
Analysis (TRA), PenTest, FMEA and NIST Framework CSF 2.0 (800-53, 800-37)
Drive design changes based on interoperability and compliance requirements key areas like functional safety
(ISO 26262), cybersecurity, fault codes, and usability engineering
Manage customer needs and strategize product feature portfolio using risk and standardization roadmaps based on
insights from ChargeX (KPI & MREC), NACI CharIN (Charger Safety & Security), UL 2941 working groups
SQA and Systems Engineer III, Xenex, San Antonio, TX September 2020 May 2023
Manage System and Software Device Development Lifecycle activities for UV Disinfection Device development
strategy as part of FDA Class-II submission
Design System Verification, Validation, and Usability test plans to prove system performance capabilities
Reduce testing time and variation by using automation tools like MATLAB, Azure DevOps, and Test Plans
Drive the software development lifecycle as part of Quality Analysis strategy for deploying devices and provide
test evidence for FDA certification
Test Engineer, Seno Medical (Contract), San Antonio, TX March 2020 September 2020
Plan and coordinate Verification activities (Hardware and System Level) for optoacoustic and ultrasound imaging
system
Design system validation experiments and verification protocols for laser-based breast cancer detection system
Create a sampling plan and track design changes as part of the device lifecycle management using tools like Helix,
Gitlab, MasterControl
Evaluate risk factors and drive design changes based on DFMEA and UFMEA outcomes in accordance with FDA
and IEC standards (60601 & 60825)
Systems Engineer, Boston Scientific (Contract), Arden Hills, MN February 2019- March-2020
Electrophysiology (EP) Capital Equipment- Electronic Medical Equipment (EME) Group
Defined requirements strategy and planned Design Verification (DV) activities for developing clinically safe and
efficacious cardiovascular medical devices
Developed predictive models and used Design of Experiments (DOE) data to identify critical system features - cut
systems testing load by 30%
Lead systems design assurance (DA) and established a communication portal for Clinical, Software, Firmware and
Hardware teams identified critical interfaces to drive efficient product development process
System Test Engineer, Medtronic (Contract), North Haven, CT January 2018 February 2019
Minimally Invasive Therapies (MITG) - Surgical Innovations Group R&D System Test Team (Hugo RAS)
Trained test team members on test methods and operation of complex electromechanical equipment like Instron,
CMM, LabView DAQ, Autoclave, Autowash and universal programmable robots
Streamlined system level testing using statistical analysis tools like Gage R&R- Minitab
Captured new requirements in Agile, created test plans in Jama and modified existing ones based on the results of
preclinical and DV testing on the Robotic Assisted Surgery system
Biomedical Engineer, Zimmer Biomet (Contract), Warsaw, IN July 2017 January 2018
Supported sterile packaging team by testing packages and performing validations for sealers
-Instron Tensile strength, sterile barrier, transport simulation, vacuum and specimen integrity testing.
Prepared and assembled laboratory equipment to comply with cGMP and GLP specification recommended for
FDA class-II device quality assurance.
Performed Equipment Qualification and Reviewed OQ, PQ and IQ reports to comply with ISO-13485 QMS.
Biomedical Engineer, University of Florida, Gainesville, FL August 2015 June 2017
Developed LabVIEW- Data Acquisition (DAQ) driver to control magnetic force bioreactor for conditioning
magnetic nanoparticles for stem cell activation and drug targeting.
Designed and 3D printed Magnetic filters using SolidWorks to simulate EM field effects.
Hardware Engineer, Apollo Computing Laboratories (P) Ltd, Hyderabad, India July 2014 - July 2015
Supported onsite installation and training for Harness Tester/ Validation test jig
Revised the Verification and Validation protocols for MIL-Grade Products
- Updated SOPs for Thermal Analysis, Power WC estimation, Environmental and Mechanical Load tests
- Developed RT-Validation Test Jig for automated testing of module- reduced cycle from 30 to 18 hours for Signal
Integrity testing for cable assemblies and noise shielding tests
Document aviation equipment lifecycle artifacts for ISO 9001:2008 QMS audits and DO-254 Certification
- Adapted risk management tools like Derating Analysis and FMEA for predicting failure rates
- Improved MTBF (mean time between failures) from 8000 hours to 12000 hours.
EDUCATION
Master of Science in Information Technology Aug-2020 to May-2022
(Cybersecurity Risk Specialization)
University of the Cumberlands -Williamsburg, Kentucky, US
Master of Science in Biomedical Engineering Aug-2015 to May-2017
University of Florida (UF) - Gainesville, Florida, US
Bachelor of Engineering in Electrical and Electronics Engineering Aug-2010 to June 2014
Birla Institute of Technology and Science (BITS)-Pilani, - Hyderabad, Telangana, India
CERTIFICATIONS
National Instruments LabVIEW Certified Associate Developer [CLAD] April-2016-April 2018
PSSE (Product and Solution Security Engineer) May 2023 July 2024
Programming Skills: C, Java, Python
Tools: Microsoft Office (Word, Excel, PowerPoint, Visio, Project), Agile, MATLAB, Minitab, LabVIEW, Altium, FMEA, JIRA,
Windchill, Jama, SolidWorks, Polarion, TRA
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