Senior Software V&V Engineer | Medical Devices | Hyderabad

Experience: 10 - 18 Years

Location: Hyderabad

Industry: Medical Devices / Healthcare Technology

Employment Type: Full-Time

Hiring Initiative : Diversity Hiring | Women Professionals Encouraged to Apply

Job Description :

We are hiring an experienced Senior Software Verification & Validation (V&V) Engineer for a leading organization in the medical technology sector.

The ideal candidate will have strong expertise in software testing, automation framework development, and regulatory compliance within a medical device software environment.

Key Responsibilities :

- Lead end-to-end software verification and validation activities across web, mobile, cloud, and integrated software platforms.

- Develop and implement effective test strategies, test plans, and automated testing frameworks.

- Ensure compliance with medical device software standards, including IEC 62304, ISO 13485, and applicable FDA regulations.

- Manage requirements traceability, verification documentation, defect analysis, and test reporting.

- Perform functional, integration, system, and regression testing.

- Collaborate with development, product engineering, and quality teams to ensure software reliability and regulatory compliance.

- Identify opportunities to improve test automation, testing processes, and overall software quality.

- Provide technical guidance and mentoring to engineering teams.

Required Skills & Qualifications :

- 10+ years of experience in Software Testing, Software Verification & Validation, or Quality Engineering.

- Minimum 3 years of experience in regulated medical device software development or testing.

- Strong knowledge of IEC 62304, ISO 13485, and FDA 21 CFR Part 820.

- Hands-on experience in automation testing using PyTest, Playwright, Jest, REST Assured, or similar frameworks.

- Proficiency in Python, JavaScript, or TypeScript.

- Experience in medical device software V&V, requirements traceability, risk assessment, and defect management.

- Strong analytical, documentation, and stakeholder collaboration skills.

Preferred Skills :

- Cloud-native applications and microservices testing.

- API, mobile application, and web application testing.

- Hardware-software integration and connected device testing.

- Knowledge of HIPAA, GDPR, and regulated software development practices.