Vice President of Product Development : 1st Gen Transcatheter Mitral Valve Repair Concept (San Francisco)

Vice President of Product Development : 1st Gen Transcatheter Mitral Valve Repair Concept

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Global Medtech Executive Recruitment : Start-up -> Fortune 500 : IC -> C-Level : Emerging Medtech Trends & Insights

We are seeking a visionary and experienced Vice President of Research and Development to lead innovation in bioprosthetic tissue heart valves delivered via minimally-invasive, catheter-based approach.

This strategic role is responsible for defining the technology roadmap and overseeing the development of next-generation transcatheter heart valve therapies—from concept through clinical and commercial deployment.

The ideal candidate combines deep technical expertise in structural heart or cardiovascular devices with hands-on experience developing percutaneous delivery systems, and has a strong track record of leading R&D teams in highly regulated medical device environments.

Key Responsibilities:

Strategic Leadership

• Define and execute the company’s R&D strategy for transcatheter bioprosthetic heart valves and associated delivery platforms.
• Translate clinical needs, market trends, and technological opportunities into a robust and differentiated product pipeline.
• Collaborate with the CEO and executive leadership team to align R&D priorities with overall business and clinical objectives.
• Technology and Product Development
• Drive the design and development of catheter-delivered valve systems, including valve structure, fixation mechanisms, tissue integration, and delivery catheters.
• Oversee innovation in tissue processing, material science, device mechanics, and hemodynamic performance.
• Ensure that all systems are optimized for durability, ease of use, and safe percutaneous deployment.

Cross-Functional Program Leadership

• Lead a multidisciplinary team of engineers, scientists, and researchers across device design, prototyping, testing, and validation.
• Integrate R&D efforts with Regulatory, Clinical, Quality, and Operations teams to ensure efficient development, testing, and manufacturing readiness.
• Manage project portfolios and technical timelines to meet critical development milestones and go-to-market strategies.

Clinical and Regulatory Collaboration

• Guide development efforts in compliance with global regulatory requirements, including ISO 5840 for transcatheter heart valves, ISO 14971 risk management, ISO 13485, and FDA 21 CFR Part 820.
• Partner with Regulatory Affairs and Clinical Affairs on preclinical study design, first-in-human planning, and global regulatory submissions.
• Ensure robust design control processes and risk mitigation throughout all phases of development.

External Engagement and Strategic Partnerships

• Cultivate relationships with clinical key opinion leaders (KOLs), research institutions, contract development organizations (CDMOs), and technology partners.
• Represent the company’s R&D leadership in investor meetings, regulatory interactions, conferences, and scientific forums.

Key Requirements

• Advanced degree (Ph.D. preferred; MS acceptable with exceptional experience) in Biomedical Engineering, Mechanical Engineering, or a related discipline.
• 15+ years of progressive experience in medical device R&D, with at least 5 years in a senior leadership role.
• Demonstrated expertise in the development of catheter-based delivery systems for structural heart or endovascular devices.
• Proven experience taking Class III transcatheter cardiovascular devices from concept to clinical and commercial stages.
• Deep understanding of valve biomechanics, tissue handling, percutaneous deployment, and delivery catheter design.

Preferred Skills and Experience

• Direct experience with transcatheter aortic valve replacement (TAVR), mitral valve repair/replacement (TMVR), or similar interventions.
• Knowledge of preclinical (bench and animal model) and clinical testing requirements for transcatheter devices.
• Experience in fast-paced startup or emerging growth company environments.
• Portfolio of issued patents, scientific publications, or thought leadership in transcatheter valve technologies.

Seniority level

• Executive

Employment type

• Full-time

Job function

• Engineering, Product Management, and Strategy/Planning

Industries

• Medical Equipment Manufacturing and Biotechnology Research