Verification & Validation
Full lifecycle ownership — test planning, design, execution, and traceability for production software releases.
Senior SW QA Engineer at Boston Scientific
John Konyan.
I make medical device software provably safe.
Six years turning firmware and embedded systems into validated, audit-ready products — from insulin pumps to nerve ablation devices.
IEC 62304 Owner
Class III Devices
- 0 Years in software quality & engineering
- 0 Promotions earned during Medtronic tenure
- 0 Cumulative GPA — full-time Dean's Honor List
- 0 Regulatory frameworks owned end to end
About
Quality is not a checklist.
Quality is not a checklist.
It's how the product earns trust.
I'm a Senior Software QA Engineer working on devices where a defect is not an inconvenience — it's a patient safety event.
I graduated from California State University, Northridge with a B.S. in Computer Science and went straight into regulated medical software. At Medtronic I owned the IEC 62304 software lifecycle and validated embedded insulin pump systems under FDA 21 CFR Part 820. Today, at Boston Scientific, I lead design quality assurance for a newly acquired Basivertebral Nerve ablation platform and coordinate requirements across international teams.
Outside of work I'm usually under the hood of a car. It's the same instinct that drives my engineering: take it apart, find out exactly why it behaves the way it does, and don't stop until it's right.
Regulatory Compliance
IEC 62304, ISO 13485, ISO 14971 and FDA 21 CFR Part 820 — built into the process, not bolted on before an audit.
Embedded Systems
White box testing of device firmware, catching logic errors before they reach hardware in the field.
Automation
Reusable test scripts and libraries that cut time-to-test on regression suites for the whole team.
Experience
Where I've done the work.
Six years across Class III medical devices and public infrastructure — always at the point where software meets something real.
Senior SW QA Engineer
Apr 2026 — PresentBoston Scientific · Valencia, CA
- Leading design quality assurance for the newly acquired Basivertebral Nerve (BVN) Ablation device.
- Perform test validation protocols for production firmware releases of the BVN Ablation device.
- Assess NCEP/CAPA hazards and maintain a full traceability matrix adhering to ISO 13485 and FDA audits.
- Perform project risk analysis of the Boston Scientific GX1 platform for the Chinese market release.
- Coordinate with the offshore Chinese team to align design, system, software and firmware requirements with local governance.
- Design Quality Assurance
- ISO 13485
- NCEP / CAPA
- Traceability Matrix
- Risk Analysis
- Global Release
Sr. Software Test Engineer
Jan 2022 — Apr 2026Medtronic · Northridge, CA · Promoted twice
- Directed the full project lifecycle for software validation and verification (V&V) — test planning, design and execution — under FDA 21 CFR Part 820 and GMP standards.
- Acted as Primary Process Owner for IEC 62304 software lifecycle processes, enforcing compliance across ISO 13485 (QMS) and ISO 14971 (Risk Management).
- Managed risk mitigation for complex device firmware by identifying logic errors during White Box testing, directly improving embedded system reliability.
- Designed and executed manual and automated test cases validating the performance and accuracy of embedded insulin pump systems across varied hardware configurations.
- Collaborated with data engineering and hardware teams to refine data validation logic and requirements traceability.
- Developed reusable test scripts and libraries, improving team productivity by reducing time-to-test for regression suites.
- Created and validated Windchill 11 & 12 tickets to manage test cycles, defects, system/user requirements and reports.
- Participated in code and documentation reviews, contributing a data validation and user experience perspective on regulatory and usability standards.
- IEC 62304
- FDA 21 CFR Part 820
- ISO 14971
- White Box Testing
- Test Automation
- Embedded Firmware
- Windchill 11 & 12
Software Engineer I
Jan 2020 — Jan 2021Department of Beaches and Harbors · Marina Del Rey, CA
- Integrated SQL databases used to track boat registration at the Marina Del Rey pier.
- Helped drive the push to cloud data storage for better data optimization.
- Maintained the Department of Beaches and Harbors boat registration system.
- SQL
- Database Integration
- Cloud Migration
Capabilities
The toolkit behind the results.
Languages & Tools
- Python
- Java
- JavaScript
- SQL
- HTML
- CSS / SCSS
- Flask
- Git & GitHub
- VS Code
Test & Validation
- Software V&V
- Test Planning & Design
- White Box Testing
- Test Automation
- Regression Suites
- Validation Protocols
- Defect Management
Regulatory & Quality
- IEC 62304
- ISO 13485
- ISO 14971
- FDA 21 CFR Part 820
- GMP
- NCEP / CAPA
- Traceability Matrix
- Windchill 11 & 12
Data & Leadership
- Data Analytics
- Data Visualization
- Knowledge Discovery
- Risk Analysis
- Cross-functional Teams
- Offshore Coordination
- Process Ownership
Projects
Things I build for fun.
Side projects where I get to design, write and ship the whole thing myself.
Work in progress
BMW Trim Finder
A Flask web app born out of my love of cars. It searches a database of 5,000 vehicles to help users pin down the exact BMW trim they're after.
- Python
- Flask
- SQL
Live
This Portfolio
A hand-built, fully responsive single page deployed on GitHub Pages — scroll animations, light and dark appearance, and a working contact form with no backend.
- HTML
- CSS / SCSS
- JavaScript
- GitHub Pages
Live
HookahByHov.com
A business website for a hookah catering company, built with Claude Code. Guests build their own package and send an inquiry straight to the owner.
- Web App
- Claude Code
- Client Work
Education
Still learning.
M.S., Engineering Management — Data Analytics
Graduate program — currently enrolled
Coursework
- Data Analytics for Engineering Managers
- Knowledge Discovery from Databases
- Data Visualization
- Decision Tools
- Entrepreneurship & Innovation
- Engineering Economy & Financial Analysis
B.S., Computer Science
California State University, Northridge
Coursework
- Databases
- Algorithms
- Programming Languages
- Software Engineering
- Web Engineering
- Database Design
- Computer Architecture
- Machine Learning
- Operating Systems
- Calculus II
- Linear Algebra
Contact
Let's talk.
Open to conversations about software quality, medical devices, and anything with an engine in it.