Verification Lab Lead - Medical Devices & Validation

Real; Irvine (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Real is seeking a Verification Manager in Irvine, CA to lead the expansion of its product testing capabilities and build a world-class verification organization. The role involves establishing a verification lab, coordinating IQ/OQ/PQ activities, and driving regulatory-compliant testing across R&D, Quality, and Regulatory teams.

The ideal candidate has extensive experience in medical device testing and a proven track record building testing facilities, mentoring engineers, and delivering

Qualifications

• 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.

Responsibilities

• Establish and scale a product verification lab; oversee equipment qualification and validation activities.
• Build the 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 and help establish field return investigation capabilities.
• Support post-market surveillance efforts and build a high-performing testing team as the organization grows.
• Lead and mentor engineers and technical staff to ensure rigorous verification processes and timelines.

Skills

Lab management

Verification testing

Leadership

Regulatory awareness

Cross-functional collaboration

Tools

Test equipment

Laboratory infrastructure

Job description

Real is seeking a Verification Manager in Irvine, CA to lead the expansion of its product testing capabilities and build a world-class verification organization. The role involves establishing a verification lab, coordinating IQ/OQ/PQ activities, and driving regulatory-compliant testing across R&D, Quality, and Regulatory teams.

The ideal candidate has extensive experience in medical device testing and a proven track record building testing facilities, mentoring engineers, and delivering