Verification Manager

About the role

We're partnering with an innovative cardiovascular medical device company to add a Verification Manager who will lead the expansion of its product testing capabilities and build a world-class verification organization. This is a unique opportunity for someone who enjoys creating systems from the ground up, leading technical teams, and playing a critical role in bringing breakthrough medical technologies to market.

The Verification Manager will establish and scale a product verification lab, oversee equipment qualification and validation activities, and build the infrastructure needed to support both product development and future commercialization efforts. This individual will work closely with R&D, Quality, and Regulatory teams while serving as a key bridge between U.S. and international operations.

Beyond overseeing verification activities, this leader will help establish field return investigation capabilities, support post-market surveillance efforts, and build a high-performing testing team as the organization continues to grow. The role offers significant visibility and influence, making it ideal for someone who wants to combine technical expertise with leadership and operational ownership.

Responsibilities

• Establish and scale a product verification lab
• Oversee equipment qualification and validation activities
• Build infrastructure to support product development and future commercialization
• Collaborate with R&D, Quality, and Regulatory teams
• Serve as a bridge between U.S. and international operations
• Establish field return investigation capabilities
• Support post-market surveillance efforts
• Build and lead a high-performing testing team

Requirements

• 5-10+ years of experience in medical device testing, verification, or laboratory operations within a regulated environment
• Experience building or expanding testing laboratories, including equipment qualification, calibration programs, test method validation, and SOP development
• Strong understanding of IQ/OQ/PQ activities and FDA-compliant testing practices
• Hands-on experience testing catheters, disposable medical devices, or other complex medical technologies
• Experience supporting both capital equipment and disposable device verification
• Previous experience leading or mentoring engineers and technical staff (preferred)

Schedule

This position is based in Irvine, California with a hybrid schedule and approximately 20-30% travel, including collaboration with international engineering teams.

Benefits

In addition to base pay, direct-hire employees may be eligible for client-offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.