About the RoleThe 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.
Ready to Shape the Future of Healthcare?Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS. 
