Associate Failure Analysis Engineer

Responsibilities

• Perform product testing and failure analysis to conduct post-market investigations of FDA-approved medical devices
• Execute investigation triage and deep-dive root cause analysis to develop failure hypotheses
• Partner with quality assurance engineers to implement and maintain effective inspection and testing procedures
• Generate, review, and maintain Quality records including NCR, CAPA, and internal audits
• Review Lot Acceptance records and DHRs to create trend charts and collect quality data
• Evaluate process flow and engineering controls using Lean Six Sigma methodology to improve safety and efficiency
• Assist in gathering information during FDA and ISO 13485 inspections

Requirements

• Bachelor’s Degree in an engineering or scientific discipline, or equivalent experience
• Proficiency in MS Office, specifically MS Excel for data analysis and chart creation
• Strong technical writing skills and ability to maintain organized, accurate records
• Ability to work onsite in a lab/plant environment and operate basic hand tools

Preferred Qualifications

• Electrical or mechanical engineering background
• Experience in a regulated medical device industry (QSR or ISO 13485)
• Knowledge of Six Sigma, Lean, SPC, ASQ, or ISO process controls
• Prior experience in a quality-related function or a bio-hazard/lab environment

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• Employee wellness programs

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The company specializes in wearable, tubeless insulin delivery systems and is a global pioneer in improving health outcomes through revolutionary medical technology.