Description

About ExThera Medical
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.

Chief Operating Officer

Description

Similar Jobs

Like this job? Get alerts for similar ones

ExThera Medical

Pipeline

Career Resources