Associate Failure Analysis Engineer

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

Associate Failure Analysis Engineer - Acton, MA | $50/hour

Are you an engineer or quality professional with experience in product testing, root cause analysis, and quality investigations? We are seeking an Associate Failure Analysis Engineer to support post-market investigations and quality assurance activities for regulated medical devices. This is a hands-on opportunity to work in a quality-focused environment, helping identify product issues, analyze failure modes, and drive continuous improvement.

What You'll Do

• 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

Qualifications

• Bachelor's degree in Engineering, Science, or a 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

Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks Program
• Health Savings Account (HSA)
• Accidental Death & Dismemberment (AD&D) Insurance

Apply today to join a collaborative engineering team in Acton, MA and gain valuable experience in quality engineering, medical device investigations, and failure analysis.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

About Us

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.