VP, R&D - Delivery System
Kardion•Irvine, CA
•$200,000 - $300,000•Onsite
About The Position
The VP, R&D – Delivery System owns the architecture, design, performance, and commercialization readiness of every delivery system component in Kardion’s MCS-class percutaneous circulatory support system — introducers, guidewires, loaders, and other procedural enablers. This is an executive technical leadership role, guiding the delivery system effort from early feasibility through design verification, system testing, and clinical readiness, in close partnership with Kardion’s Stuttgart-based engineering team.
Requirements
- BS or MS in Mechanical Engineering, Biomedical Engineering, or a related field.
- 10+ years in medical device R&D, including 5+ years leading complex disposable or pump-based systems.
- Class III cardiovascular device experience.
- Demonstrated experience designing catheter-based delivery systems (introducers, guidewires, loaders, or similar accessories).
Nice To Haves
- PhD in Mechanical Engineering, Biomedical Engineering, or a related field.
- Experience supporting clinical trials and PMA submissions.
- A track record building and leading high-performing technical teams, ideally in a startup or fast-scaling environment.
- Comfort partnering across time zones and cultures, including with international engineering teams.
Responsibilities
- Own the architecture of all delivery system components used to introduce, gain vascular access, guide the pump into place, and support the desired indwell time.
- Lead design and optimization of introducers, guidewires, and other delivery system components.
- Direct selection of high-performance polymers, metals, nitinol structures, and coatings for blood compatibility, fatigue resistance, and placement stability.
- Own design verification (DV) strategy for delivery system accessories, including simulated-use, procedural, and reliability testing.
- Partner with Operations and Supply Chain to scale from low-volume builds to repeatable manufacturing (DFM/DFA).
- Collaborate daily with Kardion’s Germany-based pump and controller engineering teams to ensure a seamless, integrated product.
- Identify and protect patentable innovations in catheter delivery, introducers, guidewires, and pump accessories.
- Build, mentor, and retain a deeply technical, multidisciplinary engineering team.
- Own budget, timelines, and milestone delivery for delivery system workstreams, with regular executive and board reporting.
Benefits
- medical, dental, and vision coverage
- 401(k)
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Executive
