VP, R&D - Delivery System

About Kardion

Kardion is a pioneering cardiovascular medical device company dedicated to advancing mechanical circulatory support technology. With headquarters in Irvine, California, and Stuttgart, Germany, the company aims to extend and improve patient care by providing clinicians with innovative circulatory support systems.

Position Overview

The Vice President of Research and Development for the Delivery System will take full ownership of the architecture, design, and market readiness of all delivery system components integral to Kardion’s percutaneous mechanical circulatory support devices. This includes introducers, guidewires, loaders, and other procedural tools. This senior technical leadership role requires guiding projects from initial feasibility through design verification, comprehensive testing, and clinical preparation while collaborating closely with the Stuttgart-based engineering team.

Key Responsibilities

• Lead the design and development of delivery system components ensuring efficient vascular access and secure placement of devices.
• Optimize and innovate introducers, guidewires, and related accessories to enhance performance and reliability.
• Select advanced materials including polymers, metals, nitinol structures, and coatings to ensure blood compatibility, durability against fatigue, and stability during indwelling times.
• Establish and direct design verification strategies encompassing simulated use, procedural, and reliability testing standards.
• Collaborate with Operations and Supply Chain teams to transition from prototype to scalable and manufacturable designs.
• Work in tandem with Kardion’s German engineering teams to guarantee product integration and functionality.
• Identify, secure, and protect intellectual property innovations related to catheter delivery and associated devices.
• Build and maintain a high-caliber, multidisciplinary engineering team through mentorship and recruitment.
• Manage budgets, timelines, and milestones, providing updates to executive leadership and the board.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a similar discipline.
• Minimum of 10 years experience in medical device R&D, including at least 5 years focused on complex disposable or pump-based systems.
• Proven experience with Class III cardiovascular devices and catheter-based delivery systems such as introducers, guidewires, and loaders.

Preferred Experience

• PhD in Mechanical, Biomedical Engineering, or related field.
• Hands-on involvement with clinical trials and Premarket Approval (PMA) applications.
• Demonstrated success in leading technical teams in startup or rapidly scaling environments.
• Comfortable working collaboratively across multiple time zones and international cultures.

Work Environment and Travel

• This position is based at the Irvine, California office and requires being onsite.
• Frequent travel up to 30% is expected, including visits to the Stuttgart, Germany office.
• Flexibility for occasional early or late meetings to accommodate Central European Time zone overlap.

Compensation and Benefits

Annual salary ranges from $250,000 to $300,000, dependent on individual qualifications and location. Comprehensive benefits include medical, dental, vision insurance, 401(k), and paid leave.

Equal Opportunity

Kardion upholds an inclusive workplace free from discrimination based on protected characteristics such as race, gender, orientation, age, disability, or veteran status.