Manager, Systems Automation @ Insulet Corporation • Bengaluru

Karthik Raja

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.

0+ Years in MedTech
0 Platform Systems Built
0 Live Product Shipped
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Engineering Leader. Product Builder.

Insulet Corporation — Systems Automation

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 Product Builder

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.

10+
Years in Healthcare
5
Platform Systems Designed
5
MedTech Companies
1
Product Shipped
" The same rigor that ensures a medical device is safe for patients can build a product people rely on every day.

The Journey

Aug 2026 — Present

Manager, Systems Automation

Insulet Corporation

  • Lead a team of SDETs for automated system-level Design Verification
  • Develop and validate automated test frameworks for medical device V&V
  • Drive continuous optimization of test processes, coverage, and efficiency
  • Apply risk-based analysis and statistical methods for test efficacy
  • Oversee CI/CD integration for verification across FDA/ISO/IEC regulated products
V&VFDAISO 13485Systems AutomationTeam Leadership
Mar 2023 — Jul 2026

Lead Test Engineer

Johnson & Johnson — Digital Surgery

  • Owned test architecture across a global digital surgery platform
  • Built unified test frameworks (Robot Framework + pytest) with CI integration
  • Designed E2E performance testing and data platform validation frameworks
  • Created AI-powered bug analysis tooling integrated with CI pipelines
  • Modernized CI/CD pipelines for IoMT embedded device SDK
Robot FrameworkPytestAzureJenkinsPythonIoMT
Oct 2021 — Jan 2023

Senior Test Engineer

L&T Technology Services — Client: Baxter

  • E2E testing for Peritoneal Dialysis devices under GDP guidelines
  • Designed 500+ test cases with BDD automation for 80+ critical scenarios
  • ISO 13485-aligned verification artifacts; 40% faster root cause analysis
PythonSeleniumBDDISO 13485
Oct 2018 — Feb 2021

Test Engineer

Fresenius Medical Care

  • System integration & regression testing for hemodialysis software (Class II, IEC 62304)
  • 200+ test cases for patient monitoring; automated workflows saving 15+ hrs/sprint
  • Zero field-reported critical defects on firmware validations
PythonIEC 62304Medical Device
Feb 2017 — Oct 2018

Biomedical Engineer

Vijaya Hospital & Apollo Hospitals

  • Managed calibration & preventive maintenance of 50+ biomedical devices
  • Reduced downtime 20% with equipment tracking system
  • Supported NABH accreditation quality audits
BiomedicalNABHQuality
Education

MBA / PGDM — Madras University (2022)

B.Tech, Electronics & Instrumentation — Anand Institute (2016)

Languages
EnglishTamilHindiMalayalam

Products from Vystra

Each product tackles a real industry problem with focused, no-nonsense software.

Live

Vystra Build

Construction Management Platform

Total site visibility for Indian civil engineering contractors. Manage projects, workers, attendance, materials, expenses, quotations — all from one platform.

12+ Modules
20 Calculators
13 Worker Skills
6 Pay Modes
  • Project & worker management with ₹ calculations
  • Auto wage calculation with OT, half/full day tracking
  • Professional quotation PDF with GST & company branding
  • Real-time profit/loss per project
Coming Soon

Next Product

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.

Ideas
Research
Build
Ship

What I Work With

Test Frameworks

Robot FrameworkPytest Pytest-BDDSelenium BDD/GherkinCucumber REST AssuredPostman

Programming

PythonGroovy Bash / ShellSQL

CI/CD & DevOps

JenkinsAzure DevOps DockerKubernetes GitHub ActionsSonarQube

Cloud & Data

Azure CloudMySQL Cosmos DBDatabricks GraphQLJFrog Artifactory

Testing Expertise

Systems AutomationDesign Verification V&VPerformance Testing API TestingEmbedded / Firmware Shift-Left TestingTDD/BDD

Domain & Leadership

ISO 13485IEC 62304 FDA SOPMedical Device Software IoMTTeam Leadership SAFe / AgileRisk-Based Testing

Thoughts & Build Logs

Writing about product building, test engineering, and the journey from idea to shipped product.

Let's Connect

Whether you want to talk MedTech, architecture, product ideas, or just say hello.