Failure Analysis Engineer

Job Title: Failure Analysis Engineer ILocation: St. Paul, MN 55117 (100% Onsite Initially, Hybrid After Training)Duration: 12 Months (W2 Contract)Shift: 8 AM - 5 PM?Position Overview:The Failure Analysis Engineer I will work in the Product Performance Engineering (PPE) Lab within the Heart Failure (HF) Division. This role focuses on CardioMEMS, a wireless monitoring system designed for patients with heart failure. CardioMEMS helps healthcare providers monitor pulmonary artery pressure (PAP)"”an early indicator of heart failure worsening"”by transmitting data to the cloud for physician review.Key Responsibilities:Conduct failure analysis and complaint investigations related to implanted devices.Analyze returned devices (electronic components and sensors) to determine root causes of failures.Investigate No Device Return (NDR) complaints (85% of cases), accessing cloud databases to analyze data logs and determine the cause of transmission issues.Collaborate with cross-functional teams to document findings and drive corrective actions.Review software and engineering logs to support failure analysis.Ensure compliance with FDA regulations and internal quality policies.Required Qualifications:Bachelor's degree in Electrical Engineering (or Biomedical Engineering with strong device investigation experience).1-3 years of industry experience in failure analysis, quality investigations, or related fields.Strong electrical and electronics background with experience in medical devicesBasic understanding of software logs and cloud-based data analysisAbility to work effectively in cross-functional teams and communicate findings clearly.Familiarity with FDA regulations and compliance requirements.Interview Process:Phone ScreeningOnsite InterviewAdditional Notes:Initial training will be 100% onsite, followed by one remote day per week upon completion of training (based on business needs).Local candidates preferred (onsite interviews required).The hiring process is moving ASAP with immediate interviews.

Created: 2025-03-09