Associate Medical Device Failure Analysis Engineer

Employee Workplace; Acton (MA); On-site; USD 57,000 - 81,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Pet Insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

Health Savings Account (HSA)

AD&D Insurance

Job summary

Employee Workplace is seeking an Associate Failure Analysis Engineer in Acton, MA who will support post-market investigations and quality assurance for regulated medical devices. You will conduct failure analyses, review DHRs, and drive CAPA activities to prevent recurrence.

The role requires strong data analysis and Excel skills, plus experience in quality engineering and documentation. This hands-on position emphasizes lean processes and cross-functional collaboration to improve testing and

Qualifications

• Bachelor's degree in Engineering, Science, or related field or equivalent experience.
• Experience in quality engineering, failure analysis, testing, or regulated manufacturing environments.
• Strong Excel and data analysis skills.
• Excellent technical writing, documentation, and organizational abilities.
• Electrical and mechanical troubleshooting experience preferred.
• Knowledge of ISO 13485, QSR, Lean Manufacturing, Six Sigma, SPC, or ASQ principles is a plus.

Responsibilities

• Conduct product testing, failure analysis, and root cause investigations.
• Perform investigation triage and develop hypotheses for product failures.
• Review quality records, device history records (DHRs), and lot acceptance documentation.
• Analyze quality data, track trends, and create reports using Excel.
• Support CAPA, NCR, training, audit, and quality system documentation.
• Partner with engineering and quality teams to improve inspection and testing processes.
• Troubleshoot new failure modes and recommend corrective actions.
• Assist with FDA and ISO audit preparation activities.
• Apply Lean Six Sigma and continuous improvement principles to enhance quality and efficiency.

Skills

Failure analysis

Root cause analysis

Quality investigations

Data analysis

Quality engineering

Documentation writing

Education

Bachelor's degree in Engineering/Science

Tools

Microsoft Excel

DHR review

CAPA tracking software

Job description

Employee Workplace is seeking an Associate Failure Analysis Engineer in Acton, MA who will support post-market investigations and quality assurance for regulated medical devices. You will conduct failure analyses, review DHRs, and drive CAPA activities to prevent recurrence.

The role requires strong data analysis and Excel skills, plus experience in quality engineering and documentation. This hands-on position emphasizes lean processes and cross-functional collaboration to improve testing and