Failure Analysis Engineer

Associate Failure Analysis Engineer – Medical DevicesLocation: Acton, MA 01720Job Type: Year Long Contract with opportunity to extendPay: $50 an hour or about $102,000 a yearPosition OverviewThe 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 ResponsibilitiesPerform 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 QualificationsBachelor’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 QualificationsExperience 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.