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 timely completion of investigations and drive to accomplish departmental and company goals. 

Responsibilities: 

• Conduct failure analysis investigations from a manufacturing perspective on returned 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. 

Minimum Requirements 

• 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. 

• Familiarity 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 verbal and excellent technical writing skills. Experience preparing technical reports and investigation summaries. 

• Strong organizational skills with attention to detail