Associate Failure Analysis Engineer

Associate Failure Analysis Engineer

Location: Acton, MA

Pay Rate: $50/hour

We are hiring an Associate Failure Analysis Engineer for a temporary contract opportunity supporting a leading medical device manufacturing environment. This hands-on quality engineering role focuses on failure analysis, root cause investigations, product testing, and quality system compliance for FDA-regulated products.

Key Responsibilities

• Conduct product testing, failure analysis, and root cause investigations.
• Perform complaint and quality investigation triage, including in-depth technical reviews.
• Analyze quality data, identify trends, and create reports using Excel.
• Review production records, lot acceptance documentation, and quality system records.
• Support CAPA, nonconformance investigations, audits, and quality compliance activities.
• Collaborate with cross-functional teams to improve product quality and manufacturing processes.
• Apply Lean and Six Sigma principles to enhance efficiency and streamline workflows.
• Assist during FDA and ISO 13485 audits and inspections.
• Troubleshoot new product failure modes and recommend corrective actions.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years of quality, manufacturing, failure analysis, or engineering experience preferred.
• Experience in medical devices, regulated manufacturing, laboratory, or quality environments is highly desirable.
• Knowledge of QSR, ISO 13485, CAPA, NCR, Lean, Six Sigma, SPC, or ASQ methodologies preferred.
• Strong Microsoft Excel skills with experience creating and analyzing charts and trends.
• Electrical and mechanical troubleshooting experience is a plus.
• Excellent technical writing, documentation, and communication skills.
• Strong attention to detail and ability to maintain accurate records.

Employee 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

If you're a detail-oriented engineer with experience in quality engineering, failure analysis, root cause investigation, and medical device manufacturing, apply today for this exciting contract opportunity in Acton, MA.

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

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