Insulet Corporation · 2 weeks ago
Associate Failure Analysis Engineer - Acton, Mass (Onsite)
Massachusetts, United States
Full-time
Onsite
Entry Level
$31/hr - $46/hr
2+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Global Product Monitoring Associate Failure Analysis Engineer is responsible for conducting post-market investigations of FDA approved medical devices, performing failure analyses, and collaborating with cross-functional teams to support continuous improvement.
Health CareMedicalMedical Device
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
Qualification
Required
Bachelor's Degree in an engineering or scientific discipline, or a minimum of 2 years of experience in an engineering or technical role
Preferred
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
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase