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MedSBOM — The Missing Open-Source FDA Compliance Tool
A free tool that turns raw SBOM scans into FDA-submission-ready documentation in seconds, not weeks.
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Karthik Raja V
Quality Engineering Leader. Product Builder.
10+ years leading test architecture and systems automation in MedTech. I build verification frameworks for medical devices at Insulet Corporation — and ship software products that solve real problems by passion.
Biomedical roots — learning how signals, safety and the human body meet inside a medical device. Where the obsession with getting it right began.
Design verification & V&V on regulated devices — authoring 500+ test cases, hunting functional defects, and engineering trust into systems lives depend on.
Building CI/CD pipelines and a performance framework that simulated 75,000 devices — turning manual checks into repeatable, shift-left quality gates.
Leading systems automation for digital surgery & connected MedTech platforms — the highest stakes, where every millisecond and every edge case matters.
The same discipline, channelled into software. Vystra Build ships live to real users — proof that quality engineering and product building are the same craft.
For a decade I've engineered trust into systems that lives depend on. Now that same discipline ships products people rely on every day. I don't chase features — I build things that hold up under pressure.
As Manager of Systems Automation, I lead a team of SDETs building automated verification frameworks for medical devices — driving design verification, V&V processes, and CI/CD pipelines across FDA/ISO/IEC regulated product development.
The same engineering discipline I bring to MedTech — risk-based thinking, shift-left strategy, quality gates — I channel into building products. Vystra Build is my first shipped product: a construction management platform for Indian contractors. It's not a side project — it's a fully shipped SaaS with 12+ modules, real users, and subscription pricing.
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The same rigor that ensures a medical device is safe for patients
can build a product people rely on every day.
9+ recognitions across quality engineering, automation, performance testing, and cross-functional delivery at J&J MedTech and Baxter.
Independently designed end-to-end load testing for medical device file ingress. Enabled 2x performance improvement and SLA commitments for Customer Success.
Nominated by Eugene Sanin • Compete
Stepped in during critical transition, owned Japan QA report-out, implemented automation scripts, and coordinated successful release validation.
Nominated by Sharath Srinivasan • Shape
Defined validation strategy, identified testing technical debt, and led functional and integration testing for faster platform delivery with improved quality.
Nominated by Subramanian Chidambaram • Connect
Led improvements in testing practices, mentored new team members, identified process gaps, and contributed to release readiness across Digital Surgery Platform.
Nominated by Paul Leinster • Shape
Testing contributions for Ottava Helper App, supporting base connectivity and building the foundation for future digital enablement.
Nominated by Sang Lee • Connect
Leadership and technical contribution achieving the IDE milestone, supporting connectivity delivery for the OTTAVA programme.
Nominated by Sang Lee • Grow
Recognised for strong collaboration, ownership, and dedication in delivering SIP02 deliverables on time with quality.
Baxter Culture Lever • Collaboration
Recognised for thorough feature testing, proactive technical understanding, and identification of valuable functional defects that strengthened product quality.
Baxter Culture Lever • Courage
Recognised for dedication, focus, and speed in supporting SIP01 test execution ahead of planned timelines.
Baxter Culture Lever • Speed
Built a post-operative recovery companion at J&J Hack4Health. AI-assisted patient check-ins with deterministic escalation rules.
Read the Build Log →Recognition from engineers and leaders across Johnson & Johnson MedTech
A decade of engineering distilled into outcomes — the systems, the scale, and the products behind the numbers.
From biomedical engineer to Manager of Systems Automation — building verification frameworks for FDA/ISO/IEC-regulated medical devices at Insulet.
Devices simulated in a performance framework
Test cases authored across regulated platforms
Modules shipped in Vystra Build SaaS
Awards at J&J for quality & performance engineering
Field-reported critical defects on firmware validations I owned — and a 2× platform performance gain from load testing.
Faster root-cause analysis with automation
Each product tackles a real industry problem with focused, no-nonsense software.
Construction Management Platform
Total site visibility for Indian civil engineering contractors. Manage projects, workers, attendance, materials, expenses, quotations — all from one platform.
Something's brewing...
The next Vystra product is in research. Could be MedTech, QA tooling, or an entirely new vertical. Follow the blog to see what takes shape.
Writing about product building, test engineering, and the journey from idea to shipped product.
A free tool that turns raw SBOM scans into FDA-submission-ready documentation in seconds, not weeks.
Read →An AI-powered system that turns failing Jenkins tests into fully-structured JIRA bugs — 30× faster.
Read →A deep-dive into realistic workload simulation, adaptive polling, and 95% API reduction at scale.
Read →How I proved Jenkins pipeline reliability with entry/exit criteria for MedTech release decisions.
Read →How MedTech discipline gave me the foundation to ship a construction management SaaS.
Read →How I built a patient recovery platform at JNJ Hack4Health that surfaces escalation signals.
Read →Why I'm documenting every product I build — the decisions, the failures, the architecture.
Read →Whether you want to talk MedTech, architecture, product ideas, or just say hello.