Chief Operating Officer

Chief Operating Officer (COO)ExThera Medical is an innovative medical device company dedicated to advancing novel blood purification technologies that address critical healthcare challenges, including infectious diseases and sepsis. Our mission is to improve patient outcomes through cutting-edge science, strong clinical partnerships, and operational excellence.Position OverviewExThera Medical is seeking a strategic and execution-oriented Chief Operating Officer (COO) with a strong quality background to lead and scale our operations. This role is critical to ensuring our products meet the highest standards of safety, compliance, and performance while driving operational efficiency and supporting company growth. The ideal candidate brings deep experience in materials-intensive medical devices and/or biotech, with a proven ability to integrate quality systems, manufacturing, and operational strategy in a fast-paced, regulated environment. This position requires a local candidate based in or near Martinez, CA, with the ability to work on-site five (5) days per week.Key ResponsibilitiesLead day-to-day operations across manufacturing, supply chain, and quality functionsEstablish and maintain a robust Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirementsPartner with executive leadership to define and execute company strategy and operational roadmapDrive operational scalability to support clinical and commercial growthOversee manufacturing processes, vendor management, and supply chain optimizationEnsure inspection readiness and lead interactions with regulatory agencies (e.g., FDA audits)Build, mentor, and lead high-performing cross-functional teamsImplement KPIs and operational metrics to improve efficiency, quality, and cost-effectivenessSupport product development and commercialization efforts with a strong quality and compliance lensQualificationsBachelor's degree in Chemical Engineering (preferred) or Chemistry required; advanced degree (MBA, MS, or equivalent) preferred15+ years of leadership experience in medical device, biotech, or life sciencesDemonstrated success in an operations leadership role (VP Operations, COO, or equivalent)Deep expertise in quality systems, regulatory compliance, and FDA/ISO standardsExperience scaling operations in a growth-stage or emerging company environmentStrong knowledge of GMP, QSR, ISO 13485, and risk management frameworksProven ability to lead through complexity and drive cross-functional alignmentExcellent communication and executive leadership skillsPreferred ExperienceBackground in blood purification, critical care, or extracorporeal therapiesExperience supporting clinical trials and commercialization of Class II/III devicesTrack record of successful regulatory inspections and product approvalsWhy Join ExThera MedicalOpportunity to shape the future of a high-impact, life-saving technologyCollaborative and mission-driven cultureVisibility and influence at the executive leadership levelCompetitive compensation, equity, and benefits packageRelocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, CA is $180,295 and $225,856. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.