Lead System V&V Engineer

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.