Biomedical / Electrical / Mechanical Engineer – Medical Device Quality

Job Description

The role involves investigating technical customer complaints and manufacturing nonconformities for medical devices through hands-on troubleshooting. The engineer will document findings, monitor complaint trends, and collaborate with cross-functional teams to implement corrective actions and process improvements.

Requirements: A Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering is strongly preferred, along with at least one year of professional engineering experience. Experience in regulated manufacturing, specifically with FDA regulations and ISO 13485, is highly desired.

Key Skills: Technical Troubleshooting, Product Evaluation, Root Cause Analysis, Quality Investigations, Complaint Handling, Medical Device Quality, SAP, Technical Documentation, ISO 13485, FDA Regulations, CAPA, Post-market Surveillance, Microsoft Excel, Analytical Skills, Cross-functional Collaboration

Benefits: Health Insurance, 401k