Job Details

Verification Manager - Medical Device

Location: Irvine, CA (hybrid, 3 days onsite) with some international travel

Position Overview

We're hiring a Verification Manager to lead the build-out of a new product verification lab in Irvine, supporting interventional cardiology testing capabilities. This role will build lab infrastructure, testing capacity, and a team from the ground up, while collaborating closely with an established core lab in Germany. Strong fit for someone who wants to build rather than inherit.

Responsibilities

• Lead build-out of the verification lab: layout planning, equipment selection/procurement, site readiness
  
• Own IQ/OQ/PQ of test equipment and processes, calibration program setup, and Test Method Validation (TMV)
  
• Develop SOPs, test protocols, and work instructions for audit-ready lab operations
  
• Support R&D by providing evaluation tools, test fixtures, and testing capabilities
  
• Travel periodically to collaborate with the international R&D team during key verification milestones
  
• Build and lead field return investigation processes for the U.S., partnering with Quality and Regulatory Affairs on MDR, CAPA, and vigilance documentation
  
• Hire, onboard, and develop the testing team as the site scales
  
• Manage lab resources, workload prioritization, and cross-functional coordination across sites

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

• Dimensional inspection/measurement systems (e.g., Keyence vision systems)
  
• Tensile and mechanical testing equipment
  
• Functional and electrical test setups for complex device assemblies
  
• Fluid flow, pressure, and leak testing for catheter-based/cardiovascular devices
  
• Programming for data analysis/tool automation
  
• Basic statistics knowledge