Systems Engineer – Complaint & Event Investigation

The Systems Engineer – Complaint & Event Investigation conducts rigorous investigations of product complaints, nonconformances, and adverse events to determine root cause and assess device and patient impact. This role supports post-market surveillance, MDR assessment, and risk management linkage while ensuring compliance with FDA regulations. The position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams to support regulatory decision-making and inspection readiness.