Failure Analysis Engineer (Onsite - Acton, MA)

The Failure Analysis Engineer is responsible for investigating failures and quality issues involving medical devices to identify root causes and support product and process improvements. This hands-on role works closely with Quality, Manufacturing, Post-Market, Supplier Quality, and Engineering teams to analyze returned products, manufacturing nonconformances, complaints, and test data, while documenting findings in technical reports and quality system records. Key responsibilities include conducting root cause investigations, analyzing failure trends, reviewing manufacturing and device history records, supporting CAPAs and quality processes, and assisting with audits and regulatory inspections. Candidates should have a bachelor’s degree in engineering and 3 to 5 years of experience in engineering, quality, reliability, or failure analysis, preferably in the medical device industry, along with strong analytical, troubleshooting, technical writing, and communication skills. Knowledge of medical device regulations, quality systems, and manufacturing processes is highly preferred.

 Position Overview:   The Failure Analysis Engineer plays an integral role in Insulet’s Quality department as a hands-on engineering role conducting investigations of FDA approved medical devices. The engineer works cross-functionally with Quality, Post-Market, Manufacturing Engineering, Supplier Quality, and Operations to ensure time ly completion of investigations and drive to accomplish departmental and company goals .

Conduct failure analysis investigations from a manufacturing perspective on re turned medical devices, manufacturing nonconformances , and other issues.   Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained .   Partner with engineering groups in Post Market, Lot Qualification, Manufacturing, Lifecycle, and Systems R&R to perform root cause analysis on complex failures and trends.   Generate, review, and maintain Quality records in support of the Quality System ( i.e : training, NCMRs, CAPAs, Quality Events, etc.)   Prepare clear, concise technical reports that summarize investigation activities, results, root cause determinations, and recommended actions. Document investigations in accordance with company procedures and regulatory requirements.   Evaluate device history records, manufacturing data, test results, inspection records, and complaint information to identify potential failure contributors.   Collect quality data and analyze failure trends and recurring issues to identify opportunities for product and process improvements.   Support internal audits, external audits, and regulatory inspections.   Evaluate process and engineering controls to improve safety and efficiency .   Perform other duties as assigned.

Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Manufacturing, Materials Science, or related discipline) or equivalent combination of education and experience .   3 to 5 years of engineering, quality, reliability, or failure analysis experience, preferably within the medical device industry.   Experience with conducting root cause investigations and technical problem-solving activities.   Excellent technical writing and communication skills.     Preferred Skills and Competencies   Knowledge of CAPA, NCMR, and Risk Management processes.   F amiliarity with QSR Part 820, ISO 13485, and ISO 14971.   Computer proficiency in MS, specifically Excel .   Electrical and mechanical background strongly preferred.   Strong analytical skills and troubleshooting skills. Ability to analyze and interpret complex data sets and test results in Excel, Minitab, or another statistical software.   Understanding of medical device manufacturing processes, including assembly, sterilization, packaging, and testing.   Effective