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Kardion

Heart pump medical device company

Global Information Technology Director

Full-Time
$200k - $245k/yr
Expert
Bachelor's
Irvine, CA, USA
In PersonFully onsite in Irvine, with periodic international travel to Stuttgart, Germany.
IT Operations

About the job

Requirements
  • At least 10 years of progressive information technology experience, including at least 4 years leading teams and owning an IT function or major domain.
  • Direct experience leading or heavily contributing to an enterprise resource planning implementation, migration, or major upgrade.
  • A proven track record building and scaling IT capability in a growing organization across internal teams and external partners.
  • Working knowledge of modern cloud, identity, and endpoint platforms sufficient to guide architecture decisions and evaluate vendor proposals.
  • Accountability for an information security program, whether delivered internally, through partners, or through a combination.
  • Experience supporting multi-site operations, including at least one international site, and ability to communicate complex technical and risk topics to executives, auditors, and non-technical business partners.
  • A bachelor's degree in information technology, computer science, or engineering, or equivalent practical experience.
  • The role is based in Irvine, California and is fully onsite.
  • Ability to support global colleagues and critical deployments outside standard business hours occasionally.
Responsibilities
  • Define and own Kardion's global IT strategy, roadmap, and budget, and serve as the primary technology advisor to the CEO and executive leadership team.
  • Establish a single global operating model across Irvine and Stuttgart, including standards, service levels, and a sustainable balance of internal capability and specialized external expertise.
  • Build, lead, and develop the global IT organization, and report on performance, risk, and investment to executive leadership.
  • Own the enterprise application portfolio and integration architecture, partnering with functional leaders to translate business requirements into system capability and maintain a coherent landscape as the company grows.
  • Provide leadership and direction to the ERP function, ensuring the program supports manufacturing, quality, supply chain, and finance at commercial scale.
  • Strengthen data management, reporting, and analytics so leadership has reliable visibility across the business.
  • Develop and own an AI governance framework covering approved tools, data protection, intellectual property, and responsible use.
  • Own computer system validation for regulated systems in partnership with Quality Assurance.
  • Ensure IT processes, controls, and documentation satisfy FDA and ISO 13485 requirements, including electronic records, access control, change control, and records retention.
  • Serve as the IT subject matter expert during regulatory inspections, notified body audits, and internal audits.
  • Own the enterprise information security program, aligned to a recognized framework and delivered through internal resources, trusted partners, or both.
  • Own incident response, third-party risk management, and IT controls that protect the integrity of business and financial systems.
  • Ensure compliance with global data privacy requirements, including GDPR and applicable US state law, in partnership with Legal and HR.
  • Own global infrastructure architecture, including cloud, identity, network, endpoint, and collaboration platforms across both sites.
  • Ensure reliable, secure, and audit-ready technology support for laboratory, engineering, and manufacturing environments.
  • Establish business continuity and disaster recovery capability, and set standards for employee onboarding and offboarding, support responsiveness, and asset management.
  • Oversee the Irvine facility and physical security and access.
  • Travel periodically to Stuttgart, Germany.
Desired Qualifications
  • Medical device, pharmaceutical, biotech, or diagnostics experience is strongly preferred.
  • Depth in one or more specialist areas within the role's scope, such as information security, infrastructure, enterprise applications, or validation.
  • Relevant certifications such as CISSP, CISM, ITIL, or PMP.

About the company

Kardion is a medical technology company developing a catheter-based heart-support system. The company researches, engineers, tests, and prepares clinical and manufacturing programs for an implantable cardiovascular device. It serves clinicians, patients, researchers, regulators, clinical partners, and medical-device suppliers. Its operating model centers on device development coordinated across engineering, clinical, quality, regulatory, and manufacturing teams. Teams work across biomedical engineering, clinical affairs, quality, regulatory, manufacturing, research, and operations. Its work connects cardiovascular medical devices expertise with coordinated delivery for clinical and healthcare stakeholders.

Company Size

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Total Funding

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Simplify Jobs

Simplify's Take

What believers are saying

  • PICANTE enrolled in 2026 across Hartford and Christ Hospital, proving active clinical execution.
  • September 2026 trial pages describe an enrolling pivotal study, not a stalled prototype.
  • Patents published in March and August 2026 strengthen bargaining power with partners and acquirers.

What critics are saying

  • PICANTE results are due December 31, 2026; a miss blocks FDA and hospital adoption.
  • Kardion shows no disclosed funding, limiting manufacturing scale and trial expansion.
  • Impella’s incumbent network at Abiomed and Johnson & Johnson crushes weak clinical superiority claims.

What makes Kardion unique

  • Kardion’s CORY P4 targets high-risk PCI with randomized head-to-head evidence against Impella CP.
  • The company owns implantable vascular support patents filed in 2026, including flow-monitoring designs.
  • Steve Williamson became CEO in August 2026, signaling a commercialization-focused MedTech team.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance

Company News

PR Newswire
Sep 22nd, 2026
Cadence Neuroscience appoints medtech executive Chris Cronin as CEO to lead clinical execution and platform growth.

Cadence Neuroscience appoints medtech executive Chris Cronin as CEO to lead clinical execution and platform growth. Cadence Neuroscience Sep 22, 2026, 09:00 ET Veteran medtech executive brings leadership experience across neuromodulation, clinical-stage company building, and commercialization; Founder Kent Leyde to lead technology and product development as CTO REDMOND, Wash., Sept. 22, 2026 /PRNewswire-PRWeb/ - Cadence Neuroscience, a clinical-stage company developing a biomarker-guided platform for personalized neuromodulation, announced the appointment of medtech executive Chris Cronin as Chief Executive Officer. Cronin joins as Cadence prepares for clinical evaluation of its investigational Biomarker Targeted Stimulation (BTS) system in focal drug-resistant epilepsy as its first indication, while building the capabilities to develop the platform across additional neurological conditions. Cronin brings nearly three decades of experience across medical technology, healthcare, finance, business development, and commercialization, including leadership experience in neuromodulation and other complex therapeutic-device categories. Kent Leyde, company founder, will become Chief Technology Officer and continue to lead Cadence's technology development, product strategy, and key external collaborations. Cronin most recently served as CEO and President of KARDION, a cardiovascular medical technology company, where he led the organization through a critical stage of growth as it moved from first-in-human to pivotal study. Previously, he held executive leadership roles at MOBĒ, helping scale the early-stage healthcare company, and spent more than a decade at Medtronic in leadership roles spanning cardiac and restorative therapies. As a Business Director at Medtronic, he held P&L responsibility across eight countries and regions for one of the company's largest franchises, with experience spanning neuromodulation modalities including deep brain stimulation, spinal cord stimulation, and intrathecal baclofen. Cadence's investigational BTS system is designed to use patient-specific neural biomarkers to inform stimulation and measure the brain's response to therapy. This biomarker-guided approach is intended to provide clinicians and researchers with real-time physiological feedback that may support more personalized and adaptable neuromodulation. Cadence is initially evaluating BTS in focal drug-resistant epilepsy, a serious condition in which many patients continue to experience seizures despite available anti-seizure medications and may have limited treatment options. This substantial unmet need makes focal drug-resistant epilepsy an important first indication for clinical evaluation of Cadence's platform. "Cadence has developed a fundamentally different approach to personalized neuromodulation - using patient-specific biomarkers not only to guide stimulation, but to measure how the brain responds," said Cronin. "The company has built a compelling technical and scientific foundation, and I'm excited to work with Kent, the board, clinical collaborators, and the broader team at this pivotal stage as we prepare for an important clinical study in focal drug-resistant epilepsy and build toward the broader potential of the Cadence platform across neurological conditions." "Chris' patient-centered approach to healthcare and medical devices is closely aligned with the way we've built Cadence from the beginning," said Leyde. "He brings deep business and medtech leadership experience at an important point in our growth. I'm pleased to have Chris leading the company while I focus on developing the technology and products at the heart of our work." "Cadence has reached an important inflection point," said Dan Moore, Independent Board Director at Cadence Neuroscience. "The company combines innovative technology with a clear initial clinical focus. Chris's experience in complex therapeutic-device categories and growth-stage medtech leadership complements Kent's continued technical leadership, positioning Cadence to execute its clinical plan and build toward future commercialization." Cadence's technology originated from research conducted by a Mayo Clinic Neurology and Neurosurgery team led by Gregory Worrell, M.D., Ph.D., a Mayo Clinic epileptologist and lead investigator. Cadence is building on this scientific foundation as it advances the BTS system through clinical evaluation. About Cadence Neuroscience Cadence Neuroscience is a clinical-stage medical technology company developing a biomarker-guided platform for personalized neuromodulation. Its investigational Biomarker Targeted Stimulation (BTS) system is designed to use patient-specific neural biomarkers to inform stimulation and measure the brain's response to therapy in real time. Cadence is initially advancing BTS in focal drug-resistant epilepsy, with a long-term goal of developing the platform for additional neurological conditions. Founded in 2017 and headquartered in Redmond, Washington, Cadence is building on technology originating from Mayo Clinic research. Cadence is backed by leading healthcare and technology investors, including F-Prime Capital, Jazz Venture Partners, LivaNova, Angelini Lumira Biosciences Fund, and Mayo Clinic. For more information, visit cadenceneuro.com. Mayo Clinic and Dr. Worrell have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research. Cadence Neuroscience is developing investigational medical technologies that have not been approved or cleared by the U.S. Food and Drug Administration (FDA) or other health authorities. Any forward-looking statements reflect current expectations and are subject to risks and uncertainties. Actual results may differ materially. This information is for educational purposes only and does not constitute medical advice or investigational device promotion. Patients should consult qualified healthcare providers regarding diagnosis and treatment options. Currently, these investigational technologies are only accessible through participation in a clinical trial. To learn more about these investigational technologies and how to access them, talk with your qualified healthcare provider or visit www.clinicaltrials.gov. Media Contact Alysa Wood, Cadence Neuroscience, 1 (425) 298-3184, [email protected], https://cadenceneuro.com/ SOURCE Cadence Neuroscience