VP, R&D - Delivery System

Summary
Location: Irvine, California (On-site)
Travel: up to 30%, including travel to Kardion’s Stuttgart, Germany office.

About Kardion
Kardion is a cardiovascular medical device company developing next-generation mechanical circulatory support technology, with dual headquarters in Irvine, California and Stuttgart, Germany. Every moment matters our team is building toward a future where circulatory support gives patients and clinicians more time, more options, and more certainty.

Position Summary

The VP, R&D – Delivery Systems is accountable for the architecture, design, performance, and commercialization readiness of all delivery system components of Kardion’s MCS-class percutaneous circulatory support platform, including introducers, guidewires, loaders, and other procedural enablers.

As a member of the executive leadership team, this individual will play a key role in building and expanding Kardion’s R&D capabilities in Irvine, California, leading the technical effort across the full product lifecyclefrom early feasibility and performance optimization through design verification, system testing, clinical readiness, and commercialization.

The role offers the opportunity to build a high-performing engineering organization in Irvine from the ground up, shape future generations of Kardion technology, and work across Kardion’s global development organization to deliver a highly differentiated clinical and customer experience.

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 all 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 closely with Product Management and Marketing to translate physician and customer needs into product requirements and differentiated user experiences.

• Collaborate across Kardion’s global R&D organization to ensure seamless integration of the delivery system, pump, controller, and accessories.

• Identify and manage third-party development partners, suppliers, and OEM organizations in partnership 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, with strong Design for Manufacturing and Assembly (DFM/DFA) 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 within Kardion

Required Qualifications

• Education: BS or MS in Mechanical Engineering, Biomedical Engineering, or a related field; PhD preferred.

• Experience: 10+ years in medical-device R&D, including 5+ years leading complex disposable, catheter-based, or pump-based systems. Class III cardiovascular device experience required; strong preference for experience supporting clinical trials, PMA submissions, and commercialization.

• Technical Skills: Catheter, introducer, and guidewire design; selection and application of high-performance polymers, metals, nitinol, and coatings; Design for Manufacturing and Assembly (DFM/DFA); design verification and reliability testing; CAD and related engineering tools.

• Leadership Skills: Demonstrated ability to build and lead high-performing technical teams, develop engineering talent, establish accountability, and drive complex programs from concept through commercialization.

• Business Skills: Strong cross-functional leadership, executive-level communication, program management, and ability to communicate effectively with senior leadership and the Board.

• Collaboration: Ability to work effectively across a global organization and integrate engineering, clinical, regulatory, quality, operations, and commercial perspectives.

• Certifications: None required; relevant professional engineering credentials are a plus.

Work Environment/Travel

• This is an Irvine, California-based leadership position with an expectation of on-site presence.

• The successful candidate will have a significant opportunity to help build and shape Kardion’s growing Irvine organization, engineering culture, and next generation of products.

• The role includes collaboration with colleagues and technical experts across Kardion’s global organization, including periodic travel to the company’s Stuttgart, Germany Innovation Center.

• Some schedule flexibility may occasionally be required to support global collaboration.

Compensation
The anticipated base salary range for this position is $250,000 – $300,000 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 Opportunity Statement
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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