Software V&V Engineer (Tool Validation) - Medical Devices

📍 Boston, MA (Onsite Mon-Thurs, Remote Fridays)
💼 Contract through April 2027, extensions thereafter
🚀 Start: ASAP

About the Opportunity

We are seeking an experienced Software Verification & Validation (V&V) Engineer to support a Tool Validation Project within a leading medical device organization. This is a high-visibility role reporting into the Sr. Software V&V Manager, where you will play a key role in validating a large portfolio of tools and ensuring compliance within a new system environment.

This is a fast-paced, high-impact assignment with direct visibility to leadership, requiring strong technical rigor and the ability to clearly track and communicate progress.

What You'll Do

• Lead validation activities for ~100+ tools as they transition from a legacy environment into a new platform
• Assess tool functionality changes and define validation strategies accordingly
• Execute and document verification & validation efforts aligned with medical device standards
• Modify, execute, and maintain validation scripts and testing processes
• Develop dashboards and reporting to communicate validation status and progress
• Collaborate with global teams across the US, Europe, and India
• Provide clear updates to leadership on risks, timelines, and progress

Required Qualifications

• 5-7+ years of experience in Software Verification & Validation, ideally in the medical device industry
• Demonstrated experience with tool validation and validation strategy development
• Strong understanding of device verification & validation processes (V&V)
• Experience assessing system/tool changes and defining validation requirements
• Ability to manage and track multiple validation efforts simultaneously
• Bachelor's degree required

Preferred Skills

• Experience with Python programming
• Exposure to database systems and validation of data-driven tools
• Experience building or using dashboards/reporting tools
• Strong analytical and documentation skills

Work Environment

• Onsite in Boston, MA (Mon-Thurs); Fridays remote