Software Verification & Validation Engineer Medical Devices

Capgemini; Pune District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Capgemini in Pune, India is seeking a Software Verification & Validation Engineer with experience in Medical Devices, Healthcare Products, or Diagnostic Imaging Systems to validate software applications and ensure regulatory compliance across the software lifecycle.

You will perform functional, system, integration, and regression testing, log defects in Jira/HP ALM, and collaborate with cross-functional teams to uphold product quality and regulatory standards.

Qualifications

• 3–8 years of experience in Software Testing or QA.
• Experience with manual testing and test lifecycle management.
• Familiarity with IEC 62304 and ISO 14971.
• Experience with HP ALM and Jira.
• Exposure to Healthcare/Medical Devices products.

Responsibilities

• Perform Functional, System, Integration, and Regression Testing.
• Execute Verification & Validation (V&V) activities for medical device software.
• Create and maintain test cases, test plans, and traceability matrices.
• Log, track, and manage defects using Jira/HP ALM.
• Collaborate with Development, Product, and Quality teams.
• Ensure compliance with medical device standards and regulatory requirements.

Skills

Manual Testing

Test Lifecycle

Regulatory Knowledge

Tools

HP ALM

Jira

Job description

We are hiring a Software Verification & Validation Engineer with experience in Medical Devices, Healthcare Products, or Diagnostic Imaging Systems. The candidate will be responsible for validating software applications, executing test strategies, ensuring regulatory compliance, and supporting product quality across the software development lifecycle.

Key Responsibilities:

• Perform Functional, System, Integration, and Regression Testing.
• Execute Verification & Validation (V&V) activities for medical device software.
• Create and maintain test cases, test plans, and traceability matrices.
• Log, track, and manage defects using tools like Jira/HP ALM.
• Collaborate with Development, Product, and Quality teams.
• Ensure compliance with medical device standards and regulatory requirements.

Required Skills:

• 3-8 years of experience in Software Testing or Quality Assurance.
• Strong experience in Manual Testing and Test Lifecycle Management.
• Knowledge of IEC 62304, ISO 14971, and software validation processes.
• Experience with HP ALM, Jira, or similar test management tools.
• Exposure to Healthcare, Medical Devices, Clinical Systems, or Diagnostic Imaging products.

Good to Have:

• API Testing (Postman)
• DICOM/PACS knowledge
• FDA/EMA regulated product experience
• Clinical Data Management Systems (CDMS/EDC)

Email : [e-mail]