Associate Failure Analysis Engineer - Acton, Mass (Onsite)

Insulet Corporation•Acton, MA

69d•$31 - $46•Onsite

About The Position

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.

Requirements

Bachelor’s Degree in an engineering or scientific discipline, or a minimum of 2 years of experience in an engineering or technical role.
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).

Nice To Haves

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.
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.

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.