Role Summary:

We are looking for an experienced Software Quality Engineer (SQE) to drive Software Verification & Validation (V&V;) activities for cloud services, edge applications, and platform solutions in a regulated medical-device software environment.

The role will focus on test planning, test automation, API and web testing, requirements traceability, defect management, release verification, and maintaining audit-ready quality documentation.

Key Responsibilities:

- Develop test strategies, test plans, test cases, and verification protocols.
- Perform manual, exploratory, integration, system, regression, and end-to-end testing.
- Review requirements, architecture, and user stories for completeness and testability.
- Develop and maintain automated tests for APIs, backend services, web applications, system and command-line tools.
- Develop automation using C#/.NET or TypeScript/JavaScript.
- Work with Playwright, Cypress, or Selenium for web automation.
- Integrate automated tests into CI/CD pipelines.
- Analyze test failures and improve test coverage and automation reliability.
- Manage end-to-end requirements traceability using Jama Connect.
- Maintain traceability between Requirements, Risk Controls, Test Cases, Test Results, and Defects.
- Prepare traceability matrices, coverage reports, test evidence, verification reports, and quality summaries.
- Log, track, verify, and retest defects using Jira/Azure DevOps.
- Perform regression impact analysis and root-cause investigations.
- Support Test Readiness Reviews (TRR), release reviews, and phase-gate assessments.
- Ensure audit-ready test documentation and approvals.
- Collaborate with Development, Product, Architecture, Quality, and Regulatory teams in an Agile/Scrum environment.

Mandatory Skills:

- 6 years of Software Testing / Software Quality Engineering experience.




- Strong experience in Software Verification & Validation (V&V;).
- Hands-on Test Automation experience.
- Strong programming experience in C#/.NET OR TypeScript/JavaScript.
- Hands-on experience with Playwright, Cypress, or Selenium.
- Strong API / REST API testing experience.
- Experience in manual, integration, system, regression, and E2E testing.
- Strong understanding of SDLC/STLC.
- Experience with CI/CD and Git.
- Experience with Jira or Azure DevOps.
- Experience working in Agile/Scrum.
- Strong understanding of defect management and test documentation.

Medical / Regulatory Experience Mandatory Priority:

- Experience testing Medical Device Software / Healthcare Software.
- Knowledge or hands-on experience with IEC 62304.
- Knowledge of ISO 13485.
- Knowledge of ISO 14971 / Risk Management.
- Understanding of FDA/MDR software guidance.
- Experience with requirements traceability and risk-based testing.
- Experience supporting audits, DHF documentation, verification evidence, or regulatory submissions is highly preferred.

Preferred Skills:

- Jama Connect.
- Cloud, distributed, or edge-based systems.
- Cybersecurity testing and vulnerability verification.
- Containers and networking.
- Authentication and security concepts.
- Linux and Windows.
- ISTQB certification.
- Experience working with regulated product development environments.

Education:

- Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Information Technology, or Electronics/related engineering discipline.

Key Competencies:

- Strong analytical and problem-solving skills.
- Excellent attention to detail.
- Strong quality and compliance mindset.
- Valuable communication and collaboration skills.
- Ability to work independently in cross-functional teams.
- Strong automation and continuous-improvement mindset.
- Sound knowledge of SDLC and Software V&V.;

📌 Software Quality Engineer - Medical Device Software (India)
🏢 Sunovaa Tech
📍 India