Director of Research Development

An innovative medical device company developing next-generation structural heart solutions is seeking an experienced Director of Research & Development to lead key product development activities from concept through commercialization. This role will provide technical and strategic leadership across device design, verification, validation, clinical support, and regulatory approval activities, with a particular focus on implantable systems and delivery technologies.

Responsibilities

• Lead the development and execution of R&D strategies for advanced Class III medical devices, ensuring alignment with business objectives, user needs, and regulatory requirements.
• Drive product innovation through all phases of development, including concept generation, design architecture, prototyping, verification, validation, clinical readiness, and commercialization.
• Provide leadership across multidisciplinary engineering teams, guiding technical decision‑making, prioritization, and execution of complex development programs.
• Oversee the design and optimization of implantable devices, delivery systems, sub-assemblies, and associated manufacturing processes.
• Establish robust test strategies and lead the development, execution, and validation of product and process test methods.
• Lead risk management activities at both subsystem and system level, ensuring a risk‑based design approach throughout development.
• Partner with manufacturing, quality, regulatory, clinical, and external stakeholders to ensure successful project delivery.
• Influence and support innovation strategy, including intellectual property development and technical differentiation.

Key Skills

• Proven leadership experience within medical device R&D, ideally in cardiovascular, structural heart, implantable, catheter‑based, or minimally invasive technologies.
• Strong technical expertise in mechanical design, biomaterials, delivery systems, implant/tissue interaction, and product development processes.
• Demonstrated success leading complex Class III medical device programs through design controls and regulatory pathways.
• Deep understanding of FDA, ISO 13485, GMP, and quality system requirements.
• Experience overseeing verification and validation strategies, including test method development and execution.
• Strong strategic thinking and project leadership capabilities, with experience managing cross‑functional and geographically distributed teams.
• Ability to influence stakeholders at technical, clinical, and executive levels.
• Strong communication, presentation, and relationship‑building skills.