*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.
What You'll Work On:
Manufacturing & Production Leadership
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 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 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
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'll Contribute:
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 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
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…