Product Quality Engineer

About the role

We are seeking a Product Quality Engineer to support product complaint investigations for complex medical devices, including Defibrillators and Pacemakers. The role involves analyzing device failures, performing risk assessments, identifying root causes, and completing technical reviews of investigations. This is an assessment-based role with no hands-on device repair.

Responsibilities

• Investigate product complaints and device failures.
• Perform root cause, hazard, and risk analysis.
• Review investigation findings and approve final conclusions.
• Analyze hardware, software, and electrical component failures.
• Identify trends and support product quality improvements.
• Ensure documentation complies with FDA and quality system requirements.

Requirements

• Bachelor's degree in Electrical, Biomedical, Mechanical, or related Engineering.
• 3+ years of experience in Product Quality Engineering or Medical Device Complaint Investigations.
• Experience with Device Failure Analysis, Hazard & Risk Analysis, and Root Cause Analysis.
• Knowledge of electrical failures, PCBAs, and hardware/software-driven medical devices.
• Experience working in an FDA-regulated medical device environment.

Qualifications

• Electrical Engineering degree.
• Experience with Defibrillators, Pacemakers, or other implantable medical devices.
• Knowledge of complaint handling, CAPA, and post-market surveillance.