Chief Operating Officer

About ExThera Medical
ExThera Medical is an innovative medical device company dedicated to advancing 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 Overview
ExThera 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 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 Responsibilities

• Lead day-to-day operations across manufacturing supply chain and qualityfunctions
• 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

• Bachelors degree 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

Why Join ExThera Medical

• Opportunity to shape the future of a high-impact life-saving technology
• Collaborative and mission-driven culture
• Visibility and influence at the executive leadership level
• Competitive compensation equity and benefits package