Verification Manager

Real Staffing; Irvine (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Specialist Staffing Group is partnering with a cardiovascular medical device company to recruit a Verification Manager in Irvine, CA. This role leads building a world-class verification organization, scaling a testing lab, and aligning with R&D, Quality, and Regulatory teams across global operations.

The position offers hybrid work with 20–30% travel, focusing on establishing testing capabilities for development and commercialization of advanced medical devices like catheters and disposable

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

• Lead the establishment and scaling of a product verification lab and related infrastructure.
• Oversee equipment qualification, calibration programs, and validation activities.
• Build capabilities to support product development and future commercialization, collaborating with R&D, Quality, and Regulatory.
• Help establish field return investigation capabilities and post-market surveillance, guiding a high-performing testing team.

Skills

Lab setup

Verification testing

IQ/OQ/PQ

FDA compliance

Team leadership

Cross-functional

Job description

We're partnering with an innovative cardiovascular medical device company that is looking to add a Verification Manager to 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 be responsible for establishing and scaling a product verification lab, overseeing equipment qualification and validation activities, and building 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.

Key qualifications include:

• 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

Beyond overseeing verification activities, this leader will help establish field return investigation capabilities, support post-markete 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.

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

EOE Statement:

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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.