Senior Medical Device Verification Lead (Hybrid)

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

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