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. 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 capabilitiesBuild internal production capabilities and evaluate external production capabilitiesDesign 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 NetSuiteDevelop sophisticated inventory management strategies for raw materials, components, and finished goodsCreate demand forecasting models and production planning processesImplement supply chain risk management and business continuity plans Quality & Regulatory Excellence Ensure all manufacturing processes comply with FDA regulations for Class II medical devicesMaintain ISO 13485, 14971,10555 and 10993 quality management system standardsOversee comprehensive quality control and quality assurance programsSupport regulatory submissions and FDA interactions Team Leadership & Organizational Development Build and lead cross-functional operations teams including manufacturing, facilities, supply chain, and logisticsEstablish organizational structure and operational processesDevelop talent acquisition strategies for critical operational rolesFoster a culture of operational excellence and continuous improvement Financial Management & Strategy Develop operational budgets and cost modelsImplement cost reduction initiatives while maintaining quality standardsEstablish key performance indicators (KPis) and operational metricsSupport 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 industryPrevious 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 devicesExperience with single-use disposable sterile medical device and capital equipment productionExperience in startup and high-growth environmentsExperience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systemsDemonstrated success building MRP systems and supply chain operations from early stageExperience with direct-to-hospital sales and distribution models Required Skills & Abilities Deep knowledge of Good Manufacturing Practices (GMP) and applicable Quality System StandardsProven ability to build and scale operations teamsThorough knowledge of materials and production scheduling systems, MRP, and cycle countingExperience working within FDA/ISO regulated environmentsExperience managing departmental budgets and P&L responsibilityExperience complying with environmental health and safety regulationsDemonstrated proficiency with problem-solving tools (FMEA, DOE, SPC, etc.) and statistical techniquesExpertise interfacing with R&D and manufacturing groups to optimize device design and processesStrong project management and cross-functional collaboration skillsFinancial acumen with P&L responsibility experienceExcellent communication skills with ability to present to board and investorsStrong negotiation skills with internal and external stakeholders Compensation Range: $210,000 USD - $250,000 USD Inquis Medical is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law. Inquis Medical does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.