Software Quality Engineer - Medical Device Software

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.

- Good 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.