Associate Failure Analysis Engineer - Medical Device QA

Advantage Technical; Acton (MA); Presencial; USD 58.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

People Perks Program

Health Savings Account (HSA)

AD&D Insurance

Descripción de la vacante

Advantage Technical seeks an Associate Failure Analysis Engineer in Acton, MA to support post-market investigations and quality assurance for regulated medical devices.

You will conduct testing, perform root-cause analysis, review DHRs, and analyze data to drive CAPA actions and continuous improvement. The role involves collaboration with engineering and quality teams to enhance inspection and testing processes.

Formación

• Bachelor's degree or equivalent experience in engineering or science.
• Experience in quality engineering, failure analysis, testing, or regulated manufacturing environments.
• Strong Excel and data analysis skills.
• Excellent technical writing, documentation, and organizational abilities.

Responsabilidades

• 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

Conocimientos

Excel

Data analysis

Technical writing

Electrical troubleshooting

Mechanical troubleshooting

Quality engineering

Educación

Bachelor's degree in Engineering, Science, or related field

Herramientas

ISO 13485

QSR

Lean Manufacturing

Six Sigma

SPC

ASQ principles

Descripción del empleo

Advantage Technical seeks an Associate Failure Analysis Engineer in Acton, MA to support post-market investigations and quality assurance for regulated medical devices.

You will conduct testing, perform root-cause analysis, review DHRs, and analyze data to drive CAPA actions and continuous improvement. The role involves collaboration with engineering and quality teams to enhance inspection and testing processes.