Lead System V&V Engineer

Sop Technology Services; Pune District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Sop Technology Services in Pune is seeking a Systems Verification & Validation Engineer to drive V&V activities for Class II medical devices in the Ventilation portfolio.

You will develop test strategies, collaborate with R&D, ensure compliance with ISO 14971, IEC 60601 and ISO 13485, and support regulatory submissions and DHF reviews. Relocation to Pune is required.

Qualifications

• Experience with medical device verification and validation.
• Familiarity with V-model development and DHF processes.
• Relocation to Pune; experience with Class II devices.
• Experience with regulatory submissions preferred.

Responsibilities

• Lead product Verification & Validation activities for medical device programs.
• Develop and execute V&V plans, protocols, and test strategies.
• Review verification and validation reports and ensure compliance with product requirements.
• Collaborate with R&D teams to improve product testability and system performance.
• Support system testing, integration activities, and resolution of technical issues.
• Define system requirements, interfaces, and design verification methodologies.
• Participate in design reviews and ensure compliance with design control processes.
• Coordinate with external agencies for compliance and safety certifications.
• Support DHF reviews, regulatory submissions, and audit readiness activities.
• Work closely with engineering teams throughout the V-model development lifecycle.

Skills

ISO 14971 Risk Management

IEC 60601

ISO 13485 Audit

System Verification & Validation

Product Verification

Test Method Validation

V-Model Development

Testing Techniques

System Design & Integration

DHF Review and Compliance

Statistical Data Analysis

Job description

Role Overview

The Systems Verification & Validation Engineer will be part of the Engineering team responsible for developing and commercializing Class II medical devices within the Ventilation business. The role will focus on product verification and validation, systems engineering, test strategy development, regulatory compliance, and cross-functional collaboration with R&D, Systems Architects, and Test teams.

Key Responsibilities

• Lead product Verification & Validation activities for medical device programs.
• Develop and execute V&V plans, protocols, and test strategies.
• Review verification and validation reports and ensure compliance with product requirements.
• Collaborate with R&D teams to improve product testability and system performance.
• Support system testing, integration activities, and resolution of technical issues.
• Define system requirements, interfaces, and design verification methodologies.
• Participate in design reviews and ensure compliance with design control processes.
• Coordinate with external agencies for compliance and safety certifications.
• Support DHF reviews, regulatory submissions, and audit readiness activities.
• Work closely with engineering teams throughout the V-model development lifecycle.

Required Skills

• ISO 14971 Risk Management
• IEC 60601
• ISO 13485 Audit
• System Verification & Validation
• Product Verification
• Test Method Validation
• V-Model Development
• Testing Techniques
• System Design & Integration
• DHF Review and Compliance
• Statistical Data Analysis

Preferred Experience

• Medical device product development experience (hardware/software/consumables)
• Experience with Class II medical devices
• Ventilator or Respiratory Care device experience (preferred)
• Strong understanding of global medical device regulations

This opportunity is based in Pune. Please apply only if you are willing to relocate to Pune or open for having a face-to-face interview. Also, candidates must have experience in Medical Systems.