Associate Failure Analysis Engineer

Associate Failure Analysis Engineer

Pay Rate: ~$50.00/hour

Employment Type: Contract

Department: Quality

Position Overview

We are seeking a detail-oriented Associate Failure Analysis Engineer to support post-market investigations of FDA-approved medical devices. This hands-on role is a key part of the Quality team, focused on product testing, root cause analysis, and continuous improvement. The ideal candidate brings strong analytical skills, technical curiosity, and the ability to collaborate across cross-functional teams in a regulated environment.

Key Responsibilities

Failure Analysis & Testing

• Perform product testing and failure analysis on returned devices
• Conduct investigation triage and deep-dive analysis to develop failure hypotheses
• Troubleshoot new and emerging failure modes
• Collect, log, and trend quality data to identify patterns and opportunities for improvement

Quality Systems & Compliance

• Ensure compliance with quality standards and regulatory requirements
• Generate, review, and maintain quality system records (training, audits, NCRs, CAPAs)
• Review Lot Acceptance Records and Device History Records (DHRs)
• Support FDA and ISO 13485 inspections through documentation and data gathering

Data Analysis & Continuous Improvement

• Create and analyze trend charts and reports using Excel
• Apply Lean Six Sigma methodologies to improve processes and efficiency
• Evaluate process flows and engineering controls to enhance product safety and performance

Cross-Functional Collaboration

• Partner with Quality Assurance Engineers and internal teams to maintain effective inspection and testing procedures
• Support broader quality initiatives and continuous improvement efforts

Qualifications

Required

• Bachelor's degree in Engineering or a scientific discipline (or equivalent experience)
• Strong organizational skills and attention to detail
• Proficiency in Microsoft Office, especially Excel
• Ability to conduct root cause analysis and manage multiple investigations

Preferred

• 2+ years of experience in a quality or failure analysis role
• Experience in a regulated industry (medical device preferred)
• Familiarity with ISO 13485, QSR, SPC, ASQ, or Lean Six Sigma methodologies
• Electrical and/or mechanical background
• Experience working in a laboratory or biohazard environment

Key Skills

• Analytical thinking and problem-solving
• Technical writing and documentation
• Data analysis and trend identification
• Strong communication and collaboration abilities

Work Environment & Physical Requirements

• Combination of lab and office environment
• Sitting approximately 70% of the time; standing 30%
• Frequent lifting under 5 lbs; occasional lifting up to 50 lbs
• Ability to operate basic hand tools

Benefits

We offer a comprehensive benefits package including medical, dental, and vision insurance, 401(k), employee assistance programs, commuter benefits, and more.

Click 'Apply Now' to connect with a recruiter.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.