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Kardion

Heart pump medical device company

Vice President R&D - Delivery System

Full-Time
$250k - $300k/yr
Expert
Bachelor's, Master's, PhD
Irvine, CA, USA
In PersonPeriodic travel to Stuttgart, Germany is required; travel may be up to 30%.

About the job

Requirements
  • A BS or MS in Mechanical Engineering, Biomedical Engineering, or a related field.
  • At least 10 years of experience in medical-device research and development, including at least 5 years leading complex disposable, catheter-based, or pump-based systems.
  • Class III cardiovascular device experience.
  • Experience with catheter, introducer, and guidewire design; high-performance polymers, metals, nitinol, and coatings; Design for Manufacturing and Assembly; design verification and reliability testing; computer-aided design and related engineering tools.
  • Ability to build and lead high-performing technical teams, develop engineering talent, establish accountability, and drive complex programs from concept through commercialization.
  • Strong cross-functional leadership, executive-level communication, program management, and communication with senior leadership and the Board.
  • Ability to work across a global organization and integrate engineering, clinical, regulatory, quality, operations, and commercial perspectives.
Responsibilities
  • Provide full people-leadership responsibility for the Delivery System R&D organization and build a growing engineering team in Irvine.
  • Own the architecture and development of components used to obtain vascular access, introduce and guide the pump to its intended location, and support the desired indwell time.
  • Lead the design and optimization of expandable introducers, guidewires, loaders, and other procedural and delivery-system components.
  • Establish technical strategy, product development priorities, timelines, and execution plans for the delivery system portfolio.
  • Partner with Product Management and Marketing to translate physician and customer needs into product requirements and differentiated user experiences.
  • Collaborate across the global R&D organization to integrate the delivery system, pump, controller, and accessories.
  • Identify and manage third-party development partners, suppliers, and original equipment manufacturer organizations with Operations and Supply Chain.
  • Lead selection and application of high-performance polymers, metals, nitinol structures, coatings, and other materials, considering blood compatibility, fatigue, vascular navigation, placement stability, and manufacturability.
  • Lead delivery-system design verification strategy and execution, including simulated-use, procedural, fatigue, wear, reliability, and material-performance testing.
  • Partner with Operations and Supply Chain to transition designs from development and low-volume builds to scalable, repeatable manufacturing using Design for Manufacturing and Assembly discipline.
  • Support supplier selection, qualification, and ongoing technical performance for delivery-system components.
  • Review and approve design documentation, specifications, design outputs, and verification protocols within the delivery-system scope.
  • Build, mentor, and retain a deeply technical, multidisciplinary engineering organization.
  • Own budgets, timelines, technical milestones, and delivery-system program performance, including executive and Board reporting.
  • Identify and protect patentable innovations related to delivery systems, introducers, guidewires, accessories, and procedural technologies.
  • Provide technical development guidance to R&D leaders across the organization in coordination with the CTO, CEO, and other executive leaders.
  • Help establish Irvine as a center for product development, technical leadership, and commercialization execution.
Desired Qualifications
  • A PhD in Mechanical Engineering, Biomedical Engineering, or a related field.
  • Experience supporting clinical trials, PMA submissions, and commercialization.
  • Relevant professional engineering credentials.

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.

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Simplify's Take

What believers are saying

  • Kardion’s 2026 clinical-trial presence shows continued execution, not a dormant development program.
  • Positive 2026 trial progress can unlock hospital evaluations and distributor interest quickly.
  • Published 2026 materials show a focused team with CEO Steve Williamson and regulatory leadership.

What critics are saying

  • PICANTE results are due December 31, 2026; a miss freezes commercialization momentum.
  • Kardion still depends on trial outcomes for physician adoption against entrenched Impella competitors.
  • If Cory P4 underperforms in PCI, Kardion loses its only credible path to scale.

What makes Kardion unique

  • Kardion’s Cory P4 targets high-risk PCI with mechanical support during complex coronary interventions.
  • PICANTE enrolled in 2026, showing active clinical execution on a differentiated cardiology platform.
  • Kardion’s 2026 website emphasizes rigor, honesty, and evidence across engineering, regulatory, and manufacturing teams.

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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