The Mullings Group

Compensation

Full Description

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-inhuman 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.