About the Role

The Vice President/Senior Vice President of Electrophysiology (EP) Catheter Manufacturing will lead the development, production transition, and global scale-up of a next-generation EP catheter manufacturing organization. This executive leader will be responsible for defining and executing the end-to-end manufacturing strategy, building a high-performing team, and ensuring successful commercialization through scalable, cost-effective, and reliable manufacturing operations. The ideal candidate brings deep expertise in cardiac catheter or EP device manufacturing, demonstrated success scaling production from launch to high-volume commercialization, and extensive experience managing contract manufacturers and manufacturing transfers across global regions.

To Make an Impact, You Will:

• Develop and execute the long-term manufacturing strategy for EP catheter products from product launch through high-volume commercialization.
• Build, lead, and mentor a world-class manufacturing, operations, supply chain, and quality organization.
• Serve as the executive leader responsible for manufacturing readiness, production scale-up, operational excellence, and capacity planning.
• Partner closely with R&D, Quality, Regulatory, Clinical, and Commercial teams to support product development and market expansion.
• Define and implement a manufacturing scale-up roadmap supporting growth from approximately 50,000 units annually to 500,000+ units annually.
• Evaluate, establish, and optimize the appropriate manufacturing model, including:
• Strategic partnerships with Contract Manufacturing Organizations (CMOs)
• Hybrid manufacturing approaches
• Internal manufacturing capabilities
• Drive manufacturing process development, validation, and continuous improvement initiatives to improve efficiency, yield, and quality.
• Select, qualify, and manage global contract manufacturing partners.
• Establish robust supplier and supply chain strategies to support commercial growth and business continuity.
• Build and qualify a scalable supply network for critical components, materials, and assemblies.
• Negotiate and manage key manufacturing and supplier relationships to achieve operational, quality, and cost objectives.
• Own product cost strategy and achieve planned reductions in COGS from launch pricing to mature commercial targets.
• Drive Lean Manufacturing, Six Sigma, and operational excellence initiatives.
• Develop manufacturing KPIs and operating metrics to ensure predictable execution and performance.
• Lead manufacturing transfers and site expansions, including transfers between domestic and international manufacturing locations.
• Establish manufacturing capabilities that support global commercialization requirements while maintaining regulatory compliance and product quality.
• Ensure successful technology transfer, process validation, and operational readiness at receiving sites.

To Excel, You Will Bring:

• Bachelor's degree in Engineering, Manufacturing, Operations, or a related technical field; advanced degree preferred.
• 15+ years of progressive leadership experience in medical device manufacturing and operations.
• Experience at the Vice President or Senior Vice President level leading manufacturing organizations.
• Proven success scaling complex catheter-based or electrophysiology medical device manufacturing from development through high-volume commercialization.
• Demonstrated expertise in cardiac catheter, EP catheter, or related interventional medical device manufacturing.
• Direct experience with electrophysiology (EP) catheters, cardiac mapping catheters, ablation catheters, or related cardiovascular devices.
• Experience scaling manufacturing through multiple commercialization phases, including launch, growth, and mature production.
• Track record of delivering substantial COGS reductions through process optimization, automation, and supply chain strategy.
• Experience supporting commercial volumes exceeding 500,000 units annually.
• Deep knowledge of catheter manufacturing processes, assembly, automation, testing, and production scale-up.
• Significant experience managing Contract Manufacturing Organizations (CMOs) at commercial volumes.
• Proven track record developing and executing manufacturing transfer strategies, including domestic-to-international (OUS) transfers.
• Experience building global supply chains and qualifying suppliers for commercial-scale production.
• Strong understanding of medical device quality systems, process validation, and regulatory requirements.
• Strategic executive capable of building organizations and leading transformational growth.
• Strong business acumen with demonstrated success balancing cost, quality, capacity, and speed-to-market objectives.
• Exceptional cross-functional leadership and stakeholder management skills.
• Results-oriented leader with the ability to thrive in a fast-paced, high-growth environment.
• Ability to travel up to 15% of the time. Overnight and/or international travel may be required.
• Ability to lift 10-15 pounds.