Quality Engineer building Quality Management Systems for FDA-regulated medical devices — ISO 13485, 21 CFR Part 820, and ISO 14971. Based in Austin, TX.
I'm a Quality Engineer working on FDA-regulated medical devices, building and maintaining Quality Management Systems aligned to ISO 13485 and 21 CFR Part 820, from first design input through post-market surveillance.
My day is risk files (ISO 14971), Design Verification & Validation, CAPA, supplier qualification, and Design History Files that hold up under audit. Every traceability link, every signed record, every change order is done so that a patient never has to think about it.
I care about the boring details that make devices safe, clean requirements, honest test reports, root causes that actually find the root, and audit trails a stranger can read in five years.
Quality Engineering Intern
Dallas, TX
Clinical Engineering Intern
Hyderabad, IN
Biomedical Engineering Intern
Coimbatore, IN
Engineered a fetal atrial septoplasty device for HLHS treatment. Authored 25+ design specs aligned with FDA and ISO 14971, built functional prototypes, and produced full DHF including FMEA and V&V.
Designed a pediatric rehabilitation system integrating tongue-pressure, chewing-force, and swallow sEMG sensors for children with cerebral palsy. Built a home-based therapy concept with gamified biofeedback and smartphone integration. Completed market, stakeholder, and regulatory assessment — Class II, FDA 510(k) pathway.
Developed CAPAs and PMA documentation for a coronary stent. Analyzed FDA warning letters on QMS non-compliance and proposed compliance strategies for safety and efficacy.
Concepted an AI-powered wearable for continuous biometric tracking and predictive analytics for chronic-disease patients. Benchmarked Dexcom G7, Abbott FreeStyle Libre, and Medtronic Guardian. Designed a regulatory strategy across FDA 510(k)/De Novo, CE MDR, ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820. Sized market at ~$29B → $156B by 2032.
Dr. N.G.P. Institute of Technology · Coimbatore, India · 1 yr 1 mo
Dr. N.G.P. Institute of Technology
Dr. N.G.P. Institute of Technology
End-to-end traceability from design inputs through V&V and design transfer.
ISO 14971 hazard analysis, dFMEA, pFMEA, and risk-control verification.
Protocols, test reports, and acceptance criteria tied back to requirements.
Root-cause investigation, corrective action, and effectiveness checks built to survive audit.
Approved supplier list, supplier audits, incoming inspection, and quality agreements.
Controlled SOPs, work instructions, ECOs, and revision history with full audit trail.
M.Eng., Biomedical Engineering
B.E., Biomedical Engineering
Certified Minitab Proficient
ID · 27627524818118
Certified Minitab Beginner
ID · 04504079245050
NSF I-Corps Innovation Program
Six Sigma Yellow Belt (SSYB)
ID · 910554
Lean Six Sigma White Belt (CSSC)
ID · CSAROMKUrq
Good Laboratory Practice (GLP)
ID · 64721683
GCP — Investigational Drugs & Devices (FDA)
ID · 64721738
GCP for Clinical Investigations of Devices
ID · 64721794
GCP — Social & Behavioral Research
ID · 64721681
Working with the IACUC
ID · 64721682
RCR Basic
ID · 64721684
2D/3D CAD Modeling — Bentley Systems
Medical Imaging Equipment Procurement — ISRRT
Arduino Training — IIT Bombay
Python Programming — IIT Bombay
YMER Journal
IEEE Conference
Perplexity
HelpAge India
Looking for full-time Quality & Regulatory roles starting May 2026. Reach out — I'd love to hear from you.