Chief Operating Officer
About The Position
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. 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.
Requirements
- Bachelor’s 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
Nice To Haves
- 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
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
Benefits
- Competitive compensation, equity, and benefits package
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Executive
