Verification Lab Lead – Medical Devices & R&D

KARDION; Irvine (CA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Job summary

Kardion, a medical device company, seeks a Verification Manager to lead Irvine lab expansion, focusing on mechanical testing, R&D support, and post-market surveillance. The role requires building a capable team and ensuring compliant testing processes.

Based in Irvine, CA, the role will work in a hybrid setup with travel to Germany as needed to collaborate with the Stuttgart team and establish scalable verification capabilities.

Qualifications

• 5 to 10+ years of experience in medical device testing or verification in an FDA-regulated environment.
• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a closely related discipline.
• Demonstrated experience leading or building a testing lab, including TMV, IQ/OQ/PQ, and calibration program development.
• Hands-on experience testing catheters or similar interventional or disposable medical devices, including working with contaminated returned products.
• Experience with complex system testing involving both capital equipment (electronics) and disposable device components.
• Experience functionally managing or leading a small technical team.
• Cardiovascular device experience preferred but not required; depth in medical device verification and lab operations matters most.

Responsibilities

• Lead the build-out of Kardion’s product verification lab in Irvine, including layout planning, equipment selection and procurement, and site readiness, ensuring consistency with existing capabilities.
• Own IQ/OQ/PQ of test equipment and calibration program setup, and Test Method Validation (TMV) to support FDA-compliant test activities.
• Develop and implement SOPs, test protocols, and work instructions for repeatable, audit-ready lab operations.
• Ensure lab is equipped to support near-term R&D needs and longer-term post-market surveillance requirements.
• Oversee lab operations, including infrastructure, regulatory compliance, and support for product development.

Skills

Medical device testing

Lab operations

Team leadership

Project management

FDA-regulated environment

R&D collaboration

Interdisciplinary communication

Education

Bachelor's in Biomedical Engineering

Electrical/Mechanical Engineering degree

Tools

TMV (Test Method Validation)

Job description

Kardion, a medical device company, seeks a Verification Manager to lead Irvine lab expansion, focusing on mechanical testing, R&D support, and post-market surveillance. The role requires building a capable team and ensuring compliant testing processes.

Based in Irvine, CA, the role will work in a hybrid setup with travel to Germany as needed to collaborate with the Stuttgart team and establish scalable verification capabilities.