Failure Analysis Engineer

Primary Responsibilities:

The successful candidate will play a key part in ensuring the quality and reliability of FDA-approved medical devices by conducting post-market investigations. This hands-on position requires strong organizational skills, attention to detail, and the ability to collaborate with cross-functional teams to achieve quality and compliance goals.

Skills & Requirements:

• Bachelor's degree in engineering or scientific discipline, or equivalent experience.
• Proficiency in Microsoft Office, particularly Excel.
• Strong electrical and mechanical background preferred.
• Experience creating and analyzing charts in Excel is a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ, or ISO process controls is advantageous.
• Prior experience in a regulated industry, such as medical devices, or working in a biohazard/lab environment is preferred.
• Effective verbal communication and excellent technical writing skills.
• Ability to generate and maintain organized and accurate records.
• Physical requirements: Sitting (70%), standing (30%), frequent lifting (up to 5 lbs), occasional handling/push-pull (up to 50 lbs), and operating basic hand tools.

The Failure Analysis Engineer's responsibilities will be:

• Conduct product testing and failure analysis to ensure compliance with quality standards.
• Collaborate with quality assurance engineers and team members to implement and maintain effective inspection and testing procedures.
• Generate, review, and maintain quality records, including training documentation, internal audits, NCRs, and CAPAs.
• Perform investigation triage and deep-dive analyses to develop hypotheses for failures.
• Review Lot Acceptance records and Device History Records (DHRs) and create trend charts.
• Collect, log, and analyze quality data to identify trends and drive improvements.
• Lead quality investigations and root cause analyses.
• Assist in gathering information during FDA and ISO 13485 inspections.
• Apply Lean Six Sigma methodologies to streamline processes and improve efficiency.
• Troubleshoot new failure modes and evaluate process and engineering controls to enhance safety and performance.
• Perform other duties as assigned.