Asset Device Tracking Specialist

About Syn Cardia Systems LLC

Syn Cardia develops, manufactures, and commercializes the Syn Cardia Total Artificial Heart (STAH), the only commercially available total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada. Syn Cardia is a wholly owned subsidiary of Picard Medical Inc. (NYSE: PMI) which became a publicly traded company on August 29, 2025.

At Syn Cardia our mission is to transform and save lives through life sustaining Total Artificial Heart technology. This role is essential to delivering on that mission by ensuring that our products’ processes and systems consistently meet the highest standards of safety, reliability and performance. You will help strengthen and advance quality systems and cross functional execution in alignment with FDA ISO and international regulatory requirements.

Your work directly supports patient safety clinical outcomes and global regulatory success while reinforcing a culture of quality excellence across the organization.

• The individual is responsible for maintaining and updating device tracking systems to ensure accurate documentation of all serialized medical equipment movements.
• Collaborates closely with Customer Support to coordinate device swaps, loaners, and returns, ensuring real‑time accuracy of serial numbers, lot numbers, and device locations.
• Reconciles returned equipment, identifies discrepancies, and flags anomalies to Quality Assurance or Operations as needed.
• Generates and archives device movement reports to support compliance and audit requirements.
• Prepares documentation for FDA, ISO, and internal audits.
• Provides stakeholders with timely updates regarding device readiness and movement status.
• Performs other duties as necessary to support operational needs.
• Initiates actions that prevent nonconformities related to products, processes, and the Quality System, documenting potential quality issues and recommending or implementing solutions through designated channels.

You’ll be part of a mission-driven organization where your work has a direct impact on patient care and outcomes. The role offers the opportunity to collaborate with cross‑functional teams in a supportive and innovative environment, while playing a key role in shaping and leading quality strategy for a Class III medical device.

• Strong organizational skills with a high level of attention to detail.
• Ability to work independently while managing multiple tasks simultaneously.
• Collaborative team player who communicates clearly and effectively.
• Proficiency in data entry, reporting, and the use of ERP or device tracking systems.
• Ability to follow strict compliance, documentation, and procedural requirements in a regulated environment.
• Minimum of two years of experience in device tracking, inventory management, or regulated operations.
• High school diploma required.

• Associate or bachelor’s degree preferred.
• Familiarity with FDA and ISO documentation and traceability requirements.
• Experience with Maintenance Connection or similar ERP or device tracking systems.
• Background in medical devices, biotechnology, pharmaceutical, or aerospace industries desirable.

The working environment includes both office and warehouse settings. The role frequently requires walking, sitting, and the use of hands for data entry and packaging support. The individual may occasionally be required to bend, stoop, or lift equipment, and must be able to lift and/or move items weighing up to 30 pounds. The noise level in the work environment is typically moderate.

Specific vision abilities required for this role include close vision and the ability to adjust focus as needed.

Medical equipment manufacturing

Full‑time