Chief Operating Officer

Key Responsibilities

• Lead day-to-day operations across manufacturing, supply chain, and quality functions
• Establish and maintain a robust Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements
• Partner with executive leadership to define and execute company strategy and operational roadmap
• Drive operational scalability to support clinical and commercial growth
• Oversee manufacturing processes, vendor management, and supply chain optimization
• Ensure inspection readiness and lead interactions with regulatory agencies (e.g., FDA audits)
• Build, mentor, and lead high-performing cross-functional teams
• Implement KPIs and operational metrics to improve efficiency, quality, and cost-effectiveness
• Support product development and commercialization efforts with a strong quality and compliance lens

Qualifications

• Bachelor’s degree in Chemical Engineering (preferred) or Chemistry required; advanced degree (MBA, MS, or equivalent) preferred
• 15+ years of leadership experience in medical device, biotech, or life sciences
• Demonstrated success in an operations leadership role (VP Operations, COO, or equivalent)
• Deep expertise in quality systems, regulatory compliance, and FDA/ISO standards
• Experience scaling operations in a growth-stage or emerging company environment
• Strong knowledge of GMP, QSR, ISO 13485, and risk management frameworks
• Proven ability to lead through complexity and drive cross-functional alignment
• Excellent communication and executive leadership skills

Preferred Experience

• Background in blood purification, critical care, or extracorporeal therapies
• Experience supporting clinical trials and commercialization of Class II/III devices
• Track record of successful regulatory inspections and product approvals

Benefits

Relocation 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.