The Mullings Group
Sr. Director of R&D : Cardiovascular RF Ablation Innovation
The Mullings Group, Hayward, California, us, 94557
Overview
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.
Company & Employment
Industry: Medical Equipment Manufacturing, Engineering Services, and Manufacturing
Employment type: Full-time
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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.
Company & Employment
Industry: Medical Equipment Manufacturing, Engineering Services, and Manufacturing
Employment type: Full-time
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr