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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 SummaryWe 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.
ResponsibilitiesLab 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 verificationR&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 environmentBachelor’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 operationsPreferred Technical Skills: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 HR@kardion.com 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.
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Location: Irvine, California
Travel: up to 20%
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 Global Logistics Lead to ensure efficient and compliant movement of materials and products across all stages while driving the strategic development of Kardion global logistics capabilities.
Position Summary
This role leads the Global Logistics function for Kardion, ensuring efficient and compliant movement of materials and products across innovation pipelines, clinical programs, and market introduction. This position drives strategic development of the logistics network including transportation, warehousing, distribution centers, and 3PL relationships.
This role requires strong collaboration with cross-functional partners in Quality, Regulatory, Clinical, R&D, Finance, and other teams to advance key priorities and ensure operational success.
Responsibilities
Compensation
The anticipated base salary range for this position is $120,000 – $140,000 annually. Actual compensation will be determined based on experience, qualifications, skills, and location. Kardion offers a comprehensive benefits package including medical, dental, and vision coverage, 401(k), and paid time off.
Equal Employment Opportunity
Kardion is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.
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Location: Irvine, California
Travel: 20–30%; up to 40% based on business need
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 Director, Quality Systems and Vigilance to help build, mature, and lead critical quality systems that support compliance, audit readiness, and commercialization.
Position Summary
The Director of Quality Systems and Vigilance will play a key leadership role in building and maturing Kardion’s global Quality Management System and Post Market Surveillance capabilities. This role will be based in Irvine and will partner closely with teams in both the U.S. and Germany.
This is a hands-on, working Director role ideal for a leader who is equally comfortable setting direction and rolling up their sleeves to execute. The right candidate will bring strong Class III medical device experience, proven FDA inspection readiness leadership, and practical expertise in complaint handling, MDR, recalls, CAPA, and quality system development in a scaling environment.
Responsibilities
Lead the design, implementation, and maturation of Kardion’s global Quality Management System in alignment with applicable regulatory and quality standards.
Serve as a key leader for FDA inspection readiness, including inspection preparation, hosting, response coordination, and CAPA follow-through.
Build and strengthen Kardion’s Post Market Surveillance capabilities to support U.S. PMA/commercial readiness and global post-market compliance.
Oversee and improve processes related to complaint handling, investigations, Medical Device Reporting (MDR), recalls, field actions, and vigilance activities.
Support compliance with U.S. and EU regulatory requirements, including MDR-related quality system obligations.
Partner cross-functionally with Quality, Regulatory, Design, Supplier Quality, and other business leaders to ensure quality systems are scalable, practical, and aligned with business needs.
Lead internal quality system improvements using data, trends, and post-market insights to strengthen organizational performance and compliance.
Help define and build the future-state team structure for this function across the U.S. and Germany.
Drive a strong culture of accountability, readiness, and continuous improvement across the quality organization.
Support document control and broader quality system governance as needed.
Required Qualifications
Bachelor’s degree in engineering, life sciences, or a related field.
Director-level experience in Quality Systems, Post Market Surveillance, or a closely related quality leadership role within the medical device industry.
Strong experience in Class III medical devices.
Proven experience working in international/global organizations and managing across regions.
Demonstrated success building, standing up, or maturing QMS systems in scaling companies, especially around the ~100 employee stage.
Hands-on experience with FDA inspections and audits, including preparation, hosting, and follow-up.
Strong working knowledge of:
Quality Management Systems
Complaint handling
Medical Device Reporting
Recalls and field actions
CAPA systems and follow-through
Strong understanding of U.S. medical device quality requirements and practical experience operating in a regulated environment.
Ability to work as a true player-coach who can both lead and execute.
Preferred Qualifications
Experience in cardiovascular medical devices.
Experience managing or partnering closely with Document Control.
Experience inheriting an existing quality system and maturing it for a growing organization.
Familiarity with EU MDR requirements and post-market obligations.
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.
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 HR@kardion.com 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.
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