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 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 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 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
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
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.
