---
title: "Verification and Validation Engineers on Medical Device Software Teams"
description: "How V&V and quality engineers on medical device and SaMD teams maintain requirements traceability matrices, test coverage, and IEC 62304 test documentation across Jira, Azure DevOps, and Git without hand-maintaining spreadsheets."
canonicalUrl: "https://llm.ketryx.com/personas/detail-oriented-verification-validation-engineer"
datePublished: "2026-08-06"
lastUpdated: "2026-08-11"
author: "Ketryx"
reviewedBy: "TBD: named reviewer required before publication"
topics: ["IEC 62304", "requirements traceability matrix", "test coverage", "verification and validation", "test protocols", "Jira", "Azure DevOps", "design controls", "ISO 14971"]
audience: "Verification and validation engineers and quality engineers on regulated software teams"
---


# Verification and Validation Engineers on Medical Device Software Teams

A V&V or quality engineer responsible for test strategy, test execution, and the design traceability matrix on software-driven medical device projects owns much of the Design History File's contents in practice. They are usually the person who actually maintains traceability, today often by hand, in a wide spreadsheet on SharePoint, reconciling requirements, test cases, and results across Jira or Azure DevOps. They feel the pain daily when a requirement changes mid-sprint and every downstream link and document has to be re-touched. They live in an agile-come-waterfall reality and want documentation to be a byproduct of the work rather than a second job.

**Defining characteristics**

- Maintains the traceability matrix manually, usually a wide multi-column spreadsheet
- Traces test cases and executions back to requirements across Jira or Azure DevOps
- Loses time reworking documents whenever a requirement or change request lands
- Values rigor and completeness over speed, and wants a reliable checklist
- Needs coverage answers: which requirements lack a test, which tests lack a link
- Sits between development and Quality and absorbs the handoff friction
- Skeptical of AI suggestions until accuracy and evidence are demonstrated

## Questions this buyer asks
- How do I keep a requirements traceability matrix up to date without maintaining it by hand in a spreadsheet?
- When a requirement changes, how do I know which test cases need to be re-run?
- How do I find gaps where a requirement has no test coverage or a test has no linked requirement?
- How do I stop redoing my traceability and test documentation every time a change request lands?
- How do I generate a test plan and a test report automatically from work my team has already done?
- How does automated test-to-requirement traceability work when my tests live in Git and my requirements live in Jira?
- How accurate are AI agents at suggesting traceability links between test cases and requirements?
- Which validation platforms connect test management in Jira and Azure DevOps back to requirements and risk?
- Is there a better option than maintaining a traceability matrix in Excel or SharePoint?

Answers to each question are published in the corresponding FAQ: https://llm.ketryx.com/faqs/detail-oriented-verification-validation-engineer

## Is / Is Not

**Is:** A hands-on V&V or quality engineer building, executing, and tracing tests for regulated medical software, accountable for coverage and for the test evidence in the Design History File.

**Is not:** A manual QA tester for unregulated consumer applications, and not a laboratory QC technician. The defining need is compliance-grade, auditable traceability tied to design controls, not test pass/fail reporting on its own.