Associate Failure Analysis Engineer/ Pay rate: $50/hr.

Job Description

Job Description

Job Summary:

Insulet is seeking an Associate Failure Analysis Engineer to support its Quality Department. This role involves conducting product testing, failure analysis, troubleshooting, and root cause investigations for FDA-approved medical devices.

Key Responsibilities:

• Perform product testing, failure analysis, and root cause investigations.
• Support Quality Assurance, NCR, CAPA, and audit activities.
• Review DHR and Lot Acceptance records.
• Analyze quality data and create trend charts using Excel.
• Support FDA and ISO 13485 compliance activities.
• Identify failure modes and recommend corrective actions.
• Apply Lean Six Sigma methodologies to improve processes.

Requirements:

• Bachelor's degree in Engineering or Scientific discipline, or equivalent experience.
• Electrical or mechanical engineering background preferred.
• 2+ years of Quality experience preferred.
• Knowledge of ISO 13485, QSR, CAPA, SPC, or Six Sigma is a plus.
• Strong Excel, analytical, documentation, and problem-solving skills.
• Medical device or regulated industry experience preferred.

Note: Hands-on engineering and failure analysis experience is highly preferred.