Failure Analysis Engineer (Onsite - Acton, MA)
Core
Investigate failures and quality issues in FDA-approved medical devices to identify root causes and support product/process improvements.
Role type
Hands-on IC failure analysis engineer
Builds
Quality system records, technical reports, and CAPAs for medical device investigations
Domain
Medical devices / Quality engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, technical writing, data analysis, troubleshooting, regulatory compliance knowledge
Preferred skills
CAPA/NCMR/Risk Management processes, QSR Part 820/ISO 13485/ISO 14971 knowledge, statistical software (Minitab/Excel), medical device manufacturing processes
Technologies
Excel, Minitab
Responsibilities
Conduct failure analysis on returned devices and manufacturing nonconformances; partner with QA/Engineering for root cause analysis; generate and maintain Quality System records; prepare technical reports summarizing investigations; evaluate device history and test data; support internal/external audits and regulatory inspections.
Seniority
Mid-level, hands-on IC