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Job description
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
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.