Failure Analysis Engineer (Medical Device)

Associate Failure Analysis Engineer

Overview

The Associate Failure Analysis Engineer plays an integral role within the Quality organization as a hands‑on contributor responsible for post‑market investigations of FDA‑approved medical devices. This position requires strong organizational skills, attention to detail, the ability to collaborate across functions, and a drive to support departmental and company goals.

Responsibilities

Quality & Compliance Support

• Perform moderately complex tasks to ensure compliance with quality standards.
• Partner with quality assurance engineers and cross‑functional teams to ensure effective inspection and testing procedures are implemented and maintained.
• Generate, review, and maintain Quality System records (training, internal audits, NCRs, CAPAs).

Failure Analysis & Investigation

• Perform product testing and failure analysis activities.
• Review Lot Acceptance records and Device History Records (DHRs); create trend charts.
• Conduct investigation triage and deep‑dive analyses to develop hypotheses for failure modes.
• Collect, log, and trend quality data to identify patterns and performance shifts.
• Lead and document quality investigations and root cause analysis.
• Troubleshoot new failure modes and evaluate process/engineering controls to improve safety and efficiency.

Regulatory & Audit Support

• Assist in gathering information during FDA and ISO 13485 inspections.
• Ensure investigation documentation meets regulatory and internal Quality System requirements.

Continuous Improvement

• Evaluate process flow using Lean Six Sigma methodologies to streamline operations.
• Support improvements to testing, inspection, and documentation processes.
• Perform other duties as assigned.

Education & Experience

Minimum Requirements

• Bachelor’s degree in an engineering or scientific discipline, or equivalent experience.

Preferred Skills & Competencies

• Proficiency in Microsoft Office, especially Excel.
• Strong electrical and mechanical background preferred.
• Experience creating and analyzing charts in Excel is a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ, and/or ISO process controls is beneficial.
• Prior experience in a regulated industry (medical device preferred) and/or biohazard/lab environment.
• Approximately 2 years of experience in a Quality‑related function working with QSR and/or ISO 13485.
• Effective verbal communication and strong technical writing skills.
• Demonstrated ability to generate and maintain organized, accurate records.

Physical Requirements

• Sitting: ~70%
• Standing: ~30%
• Frequent lifting under 5 lbs
• Occasional handling (push/pull) up to 50 lbs (<5% of time)
• Ability to operate basic hand tools