Sr. Director of Operations

*This position is on-site.  If you are planning to relocate to the Bay Area please let us know in your cover letter or at the top of your resume.  We are unable to offer relocation assistance for this position*

As Senior Director of Operations, you will lead our manufacturing and operations as they scale their innovative medical device solutions. This is a pivotal leadership role for a proven operations leader who thrives in high-growth environments and has deep expertise in medical device manufacturing. You will build and scale operations from the ground up in our facility to increase volumes from 300 - 5k a month; implementing a robust MRP system, and create distribution networks that will support our company's ambitious growth trajectory.

WhatYou'llWorkOn:

Manufacturing&ProductionLeadership

• Develop and implement scalable manufacturing strategies for multiple Class II sterile disposable sterile medical devices.
• Establish strategic manufacturing partnerships and build internal production capabilities
• Build internal production capabilities and evaluate external production capabilities
• Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance. Oversee sterile packaging and device sterilization processes.
• Implement leanmanufacturing principlesanddrivecontinuous improvement initiatives

SupplyChain&SystemsDevelopment

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

Quality&RegulatoryExcellence

• Ensure all manufacturing processes comply with FDA regulations for Class II medical devices
• Maintain ISO 13485, 14971,10555 and 10993 quality management system standards
• Overseecomprehensivequalitycontroland qualityassuranceprograms
• Support regulatory submissions and FDA interactions

TeamLeadership&OrganizationalDevelopment

• 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

FinancialManagement&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

WhatYou'llContribute:

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)

ExperienceRequirements

• 10+ years of operations leadership experience in the medical device industry
• Previous Sr Director of Operations role in a medical device startup (strongly preferred)
• Proven track record scaling manufacturing operations for Class II medical devices, preferably EP or minimally invasive cardiovascular devices
• Experience with single-use disposable sterile medical device and capital 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

RequiredSkills&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