VP, R&D - Delivery System

Kardion; Irvine (CA); On-site; USD 250,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k)

Paid time off

Job summary

Kardion, an Irvine-based cardiovascular medical device company, seeks an VP, R&D – Delivery System to own the architecture, performance, and readiness of all delivery system components for MCS-based percutaneous circulatory support. Partner with Stuttgart engineers to drive design verification, testing, and clinical readiness.

The role leads a multi-disciplinary team, owns DV strategy, and collaborates with Operations to scale manufacturing while protecting patentable innovations across

Qualifications

• 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).

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 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.

Skills

Medical device R&D leadership

Catheter-based delivery systems design

Cross-functional leadership

Education

BS/MS in Mechanical or Biomedical Engineering

PhD in Mechanical or Biomedical Engineering (preferred)

Job description

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 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.

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.

Other Responsibilities

• 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.

Required Qualifications

• 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).

Preferred Qualifications

• 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.

Work Environment/Travel

• On‑site in Irvine, CA.
• Willingness to travel domestically and internationally, up to 30%, including to Kardion’s Stuttgart, Germany office.
• Occasional early or late meetings to overlap with the CET time zone.

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.