Sr. Software Instrument Verification & Validation Engineer (Lead)

Sr. Software Instrument Verification & Validation Engineer (Lead)

Location: Rochester, NY Hybrid (4 days onsite, 1 day remote)
Employment Type: Full-Time | Direct Hire with Client
Travel: Up to 10%

Overview

Our client, a leader in the medical device industry, is seeking a Senior Software Instrument Verification & Validation Engineer (Lead) to drive the formal verification and validation of complex medical devices in compliance with FDA regulations. This individual will lead a highly collaborative team, overseeing requirements-based test design, execution, and defect management in a BL2 lab environment.

The ideal candidate will have strong technical leadership skills, hands-on experience in medical device verification and validation, and the ability to work cross-functionally to ensure product quality, compliance, and launch success.

Key Responsibilities

• Lead and manage V&V resources, serving as the technical bridge between Software Development and V&V.
• Develop and execute requirements-based manual test procedures, analyze results, and document outcomes.
• Ensure adherence to design control documentation, FDA regulations, and quality standards.
• Lead test planning, scheduling, resource allocation, and team meetings.
• Document and manage system software defects, collaborating with development teams to reproduce and verify.
• Provide technical leadership to ensure timely and successful product launches.
• Mentor and develop junior engineers, fostering professional growth.
• Support resolution of field issues to maintain product integrity.
• Collaborate with cross-functional teams including Development, Integration, Quality, Marketing, and Project Management.

Qualifications

Required:

• B.S. or M.S. in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or related discipline.
• 8 years of experience in software V&V, with leadership experience (medical device environment strongly preferred).
• Strong understanding of Instrument V&V theory and application.
• Familiarity with IEC 62304, ISO 13485, ISO 14971, and FDA QSR.
• Hands-on expertise with configuration management, defect tracking, and peer review tools.
• Solid knowledge of the software test cycle, including test plans, test cases, and test reports.
• Strong organizational, analytical, and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.
• Working knowledge of product development tools and processes (Design Input/Output, V&V, Risk Management).
• Experience with Agile methodology and application lifecycle management tools.
• Professionalism, confidence, self-motivation, and proactive leadership.

Other Details:

• Ability to travel up to 10% (air, car, overnight).
• This position is not eligible for visa sponsorship.