Job Summary
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 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
NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
Additional Information:
Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $77,300.00 - $116,000.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including: Medical, dental, and vision insurance 401(k) with company match Paid time off (PTO) And additional employee wellness programsApplication Details:This job posting will remain open until the position is filled.To apply, please visit the Insulet Careers site and submit your application online.Actual pay depends on skills, experience, and education.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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