Verification Engineer Manager

KARDION; Irvine (CA); On-site; 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

About Kardion

Kardion is a medical device company advancing innovative technology to improve patient outcomes. As we continue to scale our U.S. headquarters in Irvine and strengthen our global operating model, we are seeking a

Summary

Location: Irvine, California

Travel: 20–30%

About Kardion

Kardion is a medical device company advancing innovative technology to improve patient outcomes. As we continue to scale our U.S. headquarters in Irvine and strengthen our global operating model, we are seeking a Verification Manager to help lead the expansion of Kardion’s product testing capabilities in Irvine.

Position Summary

We are hiring a Verification Manager to lead the expansion of Kardion’s interventional cardiology product testing capabilities in Irvine. With our core lab already established in Stuttgart, this role will focus on extending our testing capacity, strengthening our infrastructure, and building the team that will support design verification focused on mechanical testing, R&D, and post‑market surveillance.

This is a pivotal position at an exciting moment for the company. You’ll help shape how our testing capabilities evolve, enhance existing processes, and ensure seamless collaboration with our partners in Germany. If you thrive in environments where the work is meaningful, the stakes are high, and you have the opportunity to build rather than inherit, this role was built for you.

Responsibilities

Lab Build-Out and Management

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

R&D Support

• Work closely with the Director of R&D and engineering teams to provide the evaluation tools, test fixtures, and testing capabilities needed to develop and verify products.
• Support onsite R&D work in Irvine by ensuring the right equipment and processes are in place and accessible to engineering.
• Participate in product verification activities at the Stuttgart site, including travel to Germany for hands‑on collaboration with the R&D team during key verification milestones.

Field Return Investigations

• Build and lead the initial investigation process for field returns in the U.S., establishing Kardion’s ability to assess device complaints and failures with rigor and speed.
• Collaborate with Quality and Regulatory Affairs to ensure investigation findings are properly documented and integrated into MDR, CAPA, and vigilance processes.
• Develop the investigation infrastructure, tooling, and protocols needed to support post‑market surveillance as the company moves toward commercialization.

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 Irvine and Stuttgart teams.

Required 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 engineering or applied science discipline.
• Demonstrated experience leading or playing a significant role in building a testing lab, including TMV, IQ/OQ/PQ of test processes, and calibration program development.
• 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.
• Experience functionally managing or leading a small technical team.
• Cardiovascular device experience is preferred but not required; what matters most is depth in medical device verification and lab operations

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 [e-mail] 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.