Position Overview:
The Global Product Monitoring Associate Failure Analysis Engineer plays an integral role in Insulet’s Quality Department as a hands-on engineer conducting post market investigations of FDA approved medical devices. The role is responsible for conducting detailed failure analyses of returned products to identify root cases and support continuous improvement. Success in this role requires strong analytical skills, attention to detail, ability to collaborate effectively across cross functional teams, and drive to accomplish departmental and company goals.
Responsibilities:
Conduct product testing and failure analysis to determine root cause of post-market issues.
Perform investigation triage and deep-dive analyses to develop and validate failure hypotheses.
Review Device History Records (DHRs), Lot Acceptance Records, and other quality documentation to support investigations.
Prepare clear, timely, and compliant investigation reports that communicate findings and support post-market surveillance and vigilance activities.
Maintain accurate and complete quality records—including documentation for training, audits, and investigation —in alignment with internal procedures and regulatory standards.
Support regulatory inspections and internal audits (e.g., FDA, ISO 13485) by maintaining a clean, safe, and organized lab environment, ensuring training records are current, and assisting with documentation retrieval, demonstrations, or other inspection needs.
Partner with Engineering, Quality, and other cross-functional teams to implement and maintain inspection and testing procedures, fostering open communication and shared problem-solving.
Support trending and data analysis of complaint and nonconformance data to identify systemic issues.
Support troubleshooting of new or emerging failure modes and drive risk, design, or process improvements through escalation and user feedback.
Participate in continuous improvement projects focused on increased quality, process efficiency, and site safety.
Perform other duties as assigned.
Education and Experience:
Bachelor’s Degree in an engineering or scientific discipline, or a minimum of 2 years of experience in an engineering or technical role.
Preferred Skills and Competencies:
Working knowledge of engineering principles and scientific methods.
Ability to follow written and verbal directions and procedures.
Accountable and dependable, with strong organizational skills, the ability to prioritize effectively, and a commitment to follow through on responsibilities.
Proficiency in Microsoft applications (Outlook, Teams, PowerPoint, Excel).
Strong analytical and problem-solving skills; familiarity with root cause analysis tools (e.g., 5 Whys, Fault Tree) and quality methodologies (e.g., Lean Six Sigma, ASQ).
Experience in a regulated environment (e.g., medical device, biohazard lab).
Collaborative, innovative, and growth-minded team player who values diverse perspectives, contributes to a positive and inclusive culture, and communicates openly to drive continuous improvement.
Preferred 2 years in a quality-related function.
Familiarity with data analysis tools (e.g., Excel, Minitab, JMP) is a plus.
Programming experience (Python, R, C++) is a plus.
Physical Requirements (if applicable):
Sitting 70%, Standing 30%
Frequent lifting <5lbs
Occasional (<5% of time) handling (push/pull) up to 50lbs
Ability to operate basic hand tools
NOTE: This position requires on-site working (requires on-site office/plant/lab work).
Additional Information:


Compensation & Benefits:

For U.S.-based positions only, the annual base salary range for this role is $31.00 - $46.00

This 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 programs

Application 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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