Failure Analysis Engineer

Turn data into answers and failures into improvements as a Failure Analysis Engineer supporting FDA-approved medical devices.

Proclinical is seeking a Failure Analysis Engineer to join a dynamic team in Acton, MA.

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.

• 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.

• 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.