Product Surveillance Engineer

X-Nav Technologies, LLC is a medical device company focused on developing innovative surgical products for the dental market. X-Nav is dedicated to enhancing patient care and increasing doctor productivity through advanced solutions. Their team comprises experts in real‑time CT navigation and guidance, and dental surgery planning software. Together, they leverage cutting‑edge technology for transformative results in the field of dental medicine.

The Product Surveillance Engineer is responsible for receiving, reviewing, and triaging incoming complaints and non‑conformity reports to determine initial risk, reportability, and appropriate investigation scope. This role conducts thorough investigations of hardware failures, software issues, system performance concerns, and user‑reported events, working closely with Technical Support to obtain device logs, photographs, troubleshooting details, and returned product information. The engineer interfaces with distributors to gather complete complaint information, clarifications, and customer feedback, and documents all investigative steps, findings, and evidence in the complaint management system with a high level of accuracy and traceability.

The position requires coordination with cross‑functional teams including Engineering, Field Service, Regulatory, and Operations to support root‑cause determination, as well as performing timely failure analysis activities such as hardware tear‑downs, software behavior review, and replication attempts when applicable. The engineer contributes to corrective or preventive actions (CAPA) when systemic issues are identified. In addition, the role tracks complaint trends, supports periodic trending and metrics reviews, contributes to management reporting, and supports internal, external, and regulatory audits by providing complaint records, investigation summaries, and objective evidence.

Other tasks may be assigned.

• Bachelor’s degree in Engineering, Biomedical Engineering, or a closely related technical field or 3 years of experience in the medical device or healthcare industry
• Strong analytical skills to monitor and interpret product performance data effectively
• Highly organized, detail‑oriented, and capable of managing multiple investigations simultaneously
• Excellent communication skills for interfacing with distributors, customers, and cross‑functional teams.
• Experience in complaint handling, quality, technical support, or failure analysis within a medical device or regulated environment preferred