Asset Device Tracking Specialist at SYNCARDIA SYSTEMS LLC – Tucson, Arizona

About SynCardia Systems LLC

SynCardia develops, manufactures, and commercializes the SynCardia 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. SynCardia is a wholly owned subsidiary of Picard Medical Inc. (NYSE: PMI) which became a publicly traded company on August 29, 2025.

Why this role matters:

At SynCardia 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.

What you will do:

The individual in this role is responsible for maintaining and updating device tracking systems to ensure accurate documentation of all serialized medical equipment movements. This includes collaborating closely with Customer Support to coordinate device swaps, loaners, and returns, while ensuring real-time accuracy of serial numbers, lot numbers, and device locations. The role also involves reconciling returned equipment, identifying discrepancies, and flagging any anomalies to Quality Assurance or Operations as needed. Additionally, the individual generates and archives device movement reports to support compliance and audit requirements, prepares documentation for FDA, ISO, and internal audits, and provides stakeholders with timely updates regarding device readiness and movement status. Other duties may be assigned as necessary to support operational needs.

The individual has the authority and responsibility to initiate actions that prevent nonconformities related to products, processes, and the Quality System. This includes identifying and documenting potential quality issues, recommending or implementing solutions through designated channels, and ensuring that all instances of customer feedback related to product performance or quality are properly recorded and reported.

Why you will love working here:

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.

What we are looking for:

The position requires strong organizational skills with a high level of attention to detail, along with the ability to work independently while managing multiple tasks simultaneously. The ideal candidate is a collaborative team player who communicates clearly and effectively and demonstrates proficiency in data entry, reporting, and the use of ERP or device tracking systems. The role also requires the ability to follow strict compliance, documentation, and procedural requirements in a regulated environment.

A high school diploma is required; candidates must have a minimum of two years of experience in device tracking, inventory management, or regulated operations. Training on internal standard operating procedures and compliance requirements will be provided.

Nice to have

While not required, an associate or bachelor’s degree is preferred. Familiarity with FDA and ISO documentation and traceability requirements is beneficial, and experience with Maintenance Connection or similar ERP or device tracking systems is a plus. A background in medical devices, biotechnology, pharmaceutical, or aerospace industries is desirable but not mandatory.

Work environment:

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.

Industry:

Medical equipment manufacturing

Employment type:

Full-time