About This Opportunity

Our client is seeking an exceptional Vice President of Operations to lead our manufacturing and operations as they scale their innovative EP medical device solutions. This is a pivotal leadership role for a proven operations executive who thrives in high-growth environments and has deep expertise in medical device manufacturing.

You'll have the opportunity to build and scale operations from the ground up, in a 40K square foot facility to increase yields from 300- 30K a month; implementing a robust MRP systems, and create distribution networks that will support our company's ambitious growth trajectory.

What You'll Do

Manufacturing & Production Leadership

• Develop and implement scalable manufacturing strategies for multiple Class II and III disposable and capitol equipment sterile electro physiology medical devices
• Build internal production capabilities
• Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance
• Oversee sterile packaging and device sterilization processes
• Implement lean manufacturing principles and drive continuous improvement initiatives

Supply Chain & Systems Development

• Build comprehensive Material Requirements Planning (MRP) systems from inception using NetSuite
• Develop sophisticated inventory management strategies for raw materials, components, and finished goods
• Create demand forecasting models and production planning processes
• Implement supply chain risk management and business continuity plans

Quality & Regulatory Excellence

• Ensure all manufacturing processes comply with FDA regulations for Class II and III medical devices
• Maintain ISO 13485, 14971,10555 and 10993 quality management system standards
• Oversee comprehensive quality control and quality assurance programs
• Support regulatory submissions and FDA interactions

Distribution & Logistics

• Design and build product distribution network and fulfillment capabilities
• Develop warehousing and logistics strategies including facility planning
• Implement traceability systems for lot tracking and recall procedures
• Create customer service and technical support frameworks

Team Leadership & Organizational Development

• Build and lead cross-functional operations teams including manufacturing, facilities, supply chain, and logistics
• Establish organizational structure and operational processes
• Develop talent acquisition strategies for critical operational roles
• Foster a culture of operational excellence and continuous improvement

Financial Management & Strategy

• Develop operational budgets and cost models
• Implement cost reduction initiatives while maintaining quality standards
• Establish key performance indicators (KPIs) and operational metrics
• Support financial planning and investor reporting requirements

What You Bring

Education & Certifications

• Bachelor's degree in Engineering, Operations Management, or related field (required)
• MBA or advanced degree (preferred)
• Professional certifications such as ASQ, APICS, or PMP (plus)

Experience Requirements

• 10+ years of operations leadership experience in the medical device industry
• Previous VP of Operations role in a medical device startup (strongly preferred)
• Proven track record scaling manufacturing operations for Class II and III medical devices, preferably EP, minimally cardiovascular
• Experience with single-use disposable sterile medical device and capitol equipment production
• Experience in startup and high-growth environments
• Experience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systems
• Demonstrated success building MRP systems and supply chain operations from early stage
• Experience with direct-to-hospital sales and distribution models

Required Skills & Abilities

• Deep knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
• Proven ability to build and scale operations teams
• Thorough knowledge of materials and production scheduling systems, MRP, and cycle counting
• Experience working within FDA/ISO regulated environments
• Experience managing departmental budgets and P&L responsibility
• Experience complying with environmental health and safety regulations
• Demonstrated proficiency with problem-solving tools (FMEA, DOE, SPC, etc.) and statistical techniques
• Expertise interfacing with R&D and manufacturing groups to optimize device design and processes
• Strong project management and cross-functional collaboration skills
• Financial acumen with P&L responsibility experience
• Excellent communication skills with ability to present to board and investors
• Strong negotiation skills with internal and external stakeholders