Overview
Failure Analysis Engineer Jobs in Acton, MA at Advantage Technical
Title: Failure Analysis Engineer
Company: Advantage Technical
Location: Acton, MA
Associate Failure Analysis Engineer – Medical Devices
Location: Acton, MA 01720
Job Type: Year Long Contract with opportunity to extend
Pay: $50 an hour or about $102,000 a year
Position Overview
The Associate Failure Analysis Engineer plays an important role within the Quality organization, supporting post-market investigations of FDA-approved medical devices. This is a hands-on engineering position focused on product testing, failure analysis, root cause investigations, and quality data analysis.
The ideal candidate will have strong analytical and problem-solving skills, excellent attention to detail, and the ability to work effectively with cross-functional teams. An electrical and/or mechanical background is strongly preferred.
Key Responsibilities
- Perform product testing and failure analysis on medical devices.
- Conduct investigation triage and detailed investigations to identify potential causes of product failures.
- Develop and test hypotheses related to device failure modes.
- Perform root cause analysis and support quality investigations.
- Troubleshoot new or previously unidentified failure modes.
- Collect, document, analyze, and trend quality and product performance data.
- Review Lot Acceptance records and Device History Records (DHRs).
- Create and analyze trend charts using Microsoft Excel.
- Perform moderately complex quality-related activities to ensure compliance with established standards and procedures.
- Partner with Quality Assurance Engineers and cross-functional team members to ensure effective inspection and testing procedures are implemented and maintained.
- Generate, review, and maintain Quality System records, including training documentation, internal audits, Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs).
- Support information gathering and documentation during FDA and ISO 13485 inspections.
- Evaluate processes and engineering controls to improve product safety, quality, and operational efficiency.
- Apply Lean Six Sigma principles to evaluate process flow and identify opportunities for improvement.
Minimum Qualifications
- Bachelor’s degree in Engineering, Science, or a related technical discipline, or equivalent relevant experience.
- Approximately 2 years of experience in a Quality, Failure Analysis, Engineering, or related function.
- Strong organizational skills and attention to detail.
- Effective verbal communication and technical writing skills.
- Ability to generate and maintain accurate, organized technical and quality records.
- Proficiency with Microsoft Office, particularly Excel.
Preferred Qualifications
- Experience working with FDA Quality System Regulations (QSR) and/or ISO 13485.
- Previous experience within the medical device or another highly regulated industry.
- Hands-on electrical and/or mechanical troubleshooting experience strongly preferred.
- Experience creating, analyzing, and interpreting charts and quality data in Microsoft Excel.
- Knowledge of Lean, Six Sigma, Statistical Process Control (SPC), ASQ principles, and/or ISO process controls.
- Experience performing root cause analysis and investigating product failures.
- Experience working in a laboratory and/or biohazard environment is preferred.
