Testing Manager

Kardion•Irvine, CA

1d•Hybrid

About The Position

We are hiring a Testing Manager to lead the expansion of Kardion’s 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, 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.

Requirements

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.

Nice To Haves

Cardiovascular device experience is preferred but not required; what matters most is depth in medical device verification and lab operations
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

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.