What are the responsibilities and job description for the Sr. Director of R&D : Cardiovascular RF Ablation Innovation position at The Mullings Group?
We are seeking a strategic and hands-on Senior Director of R&D to lead the design, development, and clinical advancement of innovative medical devices, with a strong focus on catheter-based technologies.
Their technology is Pulse Field Ablation or PFA. This role will drive product innovation from early-stage concept through full-scale manufacturing, ensuring clinical efficacy, regulatory compliance, and market readiness.
The ideal candidate will bring deep experience in medical device development, catheter systems, contract manufacturing, and cross-functional leadership across engineering, clinical, and regulatory teams.
A passion for engaging with Key Opinion Leaders (KOLs) to shape product strategy and clinical relevance is highly valued.
Responsibilities
- Lead the strategic direction and execution of R&D initiatives for catheter-based medical devices.
- Drive early-stage product development including concept generation, feasibility studies, and prototyping.
- Oversee design for manufacturability (DFM), process development, and transfer to manufacturing.
- Collaborate with clinical affairs, regulatory, and marketing teams to align product development with clinical needs and market opportunities.
- Ensure all R&D activities comply with FDA, ISO 13485, and other global regulatory standards.
- Manage and mentor a high-performing team of engineers, scientists, and clinical specialists.
- Develop and manage R&D budgets, timelines, and resource planning.
- Serve as a technical expert in physician interactions, advisory boards, and clinical training.
- Support clinical trial design, protocol development, and site activation for investigational device studies.
- Provide technical support during catheter-based procedures and collaborate with field teams to optimize device performance.
- Lead engagement with contract manufacturing organizations (CMOs) to ensure quality, scalability, and timely delivery of components and finished devices.
- Engage with Key Opinion Leaders to gather insights, validate concepts, and guide clinical relevance of product development.
Qualifications
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field
- 10 years of experience in medical device R&D, with at least 5 years in a senior leadership role.
- Extensive experience in catheter development, from early-stage design through manufacturing scale-up.
- Proven experience managing contract manufacturing partnerships, including vendor selection, quality oversight, and production transfer.
- Track record of bringing Class II or Class III medical devices to market.
- Strong understanding of clinical workflows, human factors, and device usability.
- Deep knowledge of regulatory pathways including 510(k), IDE, and PMA submissions.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Willingness to travel to clinical sites, manufacturing partners, and industry events.
Preferred Experience
- Electrophysiology experience is a strong plus, but not required.
- Background in electrodes or any form of ablation is a plus.
- Ability to come to the office on a regular basis in Hayward.