Verification Engineer Manager

Summary 
Location: Irvine, California 
Travel: 20–30%
About Kardion
Kardion is a medical device company advancing innovative technology to improve patient outcomes. As we scale our U.S. headquarters in Irvine and strengthen our global operating model, we are seeking a Verification Engineer Manager to help lead the expansion of Kardion’s product testing capabilities in Irvine.
Position Summary
We are hiring for a hands-on verification role to grow Kardion’s interventional cardiology product testing capabilities in Irvine. With our core lab already established in Stuttgart, this role will focus on design verification, test method development, and post-market failure investigation for complex Class III medical devices.
This is a pivotal position at an exciting moment for the company. The scope is broader than traditional Testing or Validation Engineer position. You’ll be deeply involved in the ful l product development and testing process. We’re looking for someone who enjoys being hands-on with test equipment and devices, digging into failure data, and understanding the “why” behind test results. You’ll bring a strong understanding of both R&D and product testing, with the ability to translate that knowledge into practical, effective verification strategies.
If you thrive in environments where the work is meaningful, the stakes are high, and you have the opportunity to build something rather than inherit it, this role is for you. You’re a tinkerer and a doer with deep experience in the interventional space and familiarity with a range of complex medical devices including how they’re designed to work, how they’re tested, and what can go wrong when they don’t.
Responsibilities
Design Verification & Testing

• Lead design verification activities for interventional cardiology devices, including test method development and validation (TMV)
• Apply strong judgment around what constitutes appropriate, defensible testing for Class III devices in an FDA-regulated environment
• Evaluate complex device assemblies — including electrical/capital equipment paired with disposable components — to understand functional behavior and failure modes
• Work closely with R&D and engineering teams to translate device requirements into verification and test strategies
• Support onsite R&D work in Irvine and participate in verification activities at the Stuttgart site as needed, including travel to Germany for key milestones

Field Return Investigations

• Lead the initial investigation and evaluation of field returns and post-market failures in the U.S.
• Assess complex interventional devices for failure modes, working with contaminated returned product where applicable
• Collaborate with Quality and Regulatory Affairs to ensure findings are properly documented and integrated into MDR, CAPA, and vigilance processes
• Build the investigation infrastructure, tooling, and protocols needed to support post-market surveillance as the company scales toward commercialization

Lab Build-Out and Management

• Support the build-out and ongoing maintenance of Kardion’s verification lab in Irvine — layout, equipment selection, calibration, and site readiness — in coordination with the existing Stuttgart lab
• Own or contribute to IQ/OQ/PQ of test equipment and calibration program maintenance
• Develop and maintain SOPs, test protocols, and work instructions that support repeatable, audit-ready lab operations

Team Leadership

• Hire, onboard, and develop the Irvine testing team, building headcount and capability in line with Kardion’s expansion plan
• Lead and manage a high-performing team with clear expectations, technical mentorship, and a culture of precision and accountability
• Manage lab resources, workload prioritization, and cross-functional coordination across the Irvine and Stuttgart teams

Required Qualifications

• 5 to 10+ years of experience in medical device testing, verification, or validation in an FDA-regulated environment
• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a closely related engineering or applied science discipline
• Hands-on experience testing catheters or similar interventional or disposable medical devices, including working with contaminated returned product
• Experience with complex system testing involving both capital equipment (electronics) and disposable device components
• Demonstrated understanding of test method validation (TMV), IQ/OQ/PQ, and calibration program fundamentals
• Experience functionally managing or leading a small technical team, or clear readiness to grow into that role
• Cardiovascular device experience is preferred but not required; what matters most is depth in medical device verification and hands-on device/failure understanding

Preferred Technical Skills
Proficiency with one or more of the following is strongly preferred:

• Dimensional inspection and 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 relevant to catheter-based or cardiovascular devices
• Programming skills for data analysis and tool automation
• Basic understanding of statistics

Work Environment/Travel 
This role is based in Irvine, California and follows a hybrid schedule of 3 days in the office and 2 days working from home. Travel is expected to be approximately 20–30%, with the potential for increased travel during the first 6 months based on ramp-up and business needs, including travel to Germany. Must be flexible for early starts to overlap with the CET time zone.
Environment

• Physical Abilities: While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear up to 8 hours per day. Duties also involve daily keyboard/computer use. Specific vision abilities required by this job include close vision. The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Language Abilities: Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Work Environment: This role is based in Irvine, California and follows a hybrid schedule of 3 days in the office and 2 days working from home.
• Travel: Travel is expected to be approximately 20–30%, with the potential for increased travel during the first 6 months based on ramp-up and business needs, including travel to Germany.

Equal Opportunity Statement
Kardion is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, gender identity, sexual orientation, national origin, disability, age, or any other protected characteristic.
At-Will Employment
This position is at-will. Kardion or the employee may terminate the employment relationship at any time, with or without notice, and for any lawful reason.
Reasonable Accommodations
Applicants who require reasonable accommodation in the job application process may contact View email address on us.fitly.work to request assistance.
Why Kardion 
Join a mission-driven team at the intersection of healthcare and technology. Kardion offers exposure to complex global accounting, opportunities for professional growth, and a culture rooted in integrity, collaboration, and innovation.