Verification Validation Engineer

Job Title:

Verification & Validation Engineer.

Department:

Research & Development Verification, Validation & Compliance

Location:

Vapi, Gujarat / Pune, Maharashtra (as per business requirement)

Reports To:

Manager Verification & Validation / Head Quality & R&D

Job Purpose:

To plan, execute, and document verification and validation activities for endoscopic imaging systems, ensuring that image quality, system performance, reliability, and safety meet defined design requirements, user needs, and applicable medical device regulatory standards.

The role plays a critical part in regulatory submissions, clinical readiness, and product release.

Key Responsibilities:

1. Image Quality & System Performance Validation

Validate image quality parameters, including resolution, color accuracy, signal-to-noise ratio (SNR), contrast, dynamic range, and uniformity.

Measure and evaluate system performance metrics such as latency, frame rate, throughput, and synchronization.

Assess system behavior under clinical-like conditions, including low light, reflections, motion, and prolonged operation.

Verify end-to-end imaging performance from sensor input to video output.

2. Verification Planning & Execution

Develop and execute verification protocols, test cases, and test procedures based on design inputs and risk analysis.

Perform functional, performance, stress, and reliability testing of endoscopic imaging hardware and software.

Execute tests in accordance with approved protocols and document results in a traceable manner.

Identify, document, and track defects in collaboration with R&D teams.

3. Test Automation & Data Analysis

Develop and maintain automated test scripts (Python or equivalent) for image quality and system performance evaluation.

Analyze test data and generate objective metrics and reports.

Support repeatable, regression, and long-term testing through automation frameworks.

4. Documentation & Regulatory Support

Prepare and maintain verification reports, validation summaries, and supporting documentation.

Ensure traceability between user needs, design inputs, risk controls, and verification results.

Support regulatory submissions and audits by providing technical evidence and test documentation.

Participate in design reviews, risk management activities, and change impact assessments.

5. Cross-Functional Collaboration

Work closely with hardware, firmware, image processing, quality, and regulatory teams.

Provide objective feedback on image quality and system performance to support continuous improvement.

Support internal and external testing, including pre-compliance and system-level evaluations.

Qualifications and Experience:

B.E. / B.Tech / M.Tech in Electronics, Biomedical Engineering, Imaging, or related disciplines.

48+ years of experience in verification and validation of medical devices or imaging systems.

Experience with endoscopic imaging, medical cameras, or video systems is preferred.

Familiarity with regulated development environments and documentation practices.

Skills and Competencies:

Strong understanding of image quality evaluation methods and performance metrics.

Hands-on experience with verification planning, protocol execution, and documentation.

Proficiency in test automation and scripting (Python).

Knowledge of medical device V&V principles, traceability, and risk-based testing.

Ability to analyze data, interpret results, and communicate findings clearly.

Structured, detail-oriented working style suitable for regulated environments.

Effective collaboration and communication skills.

Key Performance Indicators (KPIs):

Accuracy and completeness of verification and validation documentation

Coverage of image quality and system performance requirements

Defect detection effectiveness and resolution cycle time

Readiness and quality of regulatory submission support

Compliance with project timelines and quality standards

Contribution to product reliability, safety, and clinical acceptance