Senior Engineer - Complaints Technical Investigations
Core
Conduct technical investigations of product complaints and design failures to identify root causes and drive product improvements for medical devices.
Role type
Senior Engineer - Complaints Technical Investigations
Builds
Improved clinical and commercial drug delivery devices and reduced complaint rates
Domain
Biotechnology / Medical Devices
Required skills
Root cause analysis, Failure analysis, Data analytics, Risk assessment, Design of experiments, Technical writing, Cross-functional leadership, Statistical analysis
Preferred skills
Six Sigma proficiency, ISO 14971 risk management, Class II/III medical device experience, Protocol writing, Continuous improvement leadership
Technologies
FMEA, Fault Tree Analysis, Fishbone diagrams, 5 Whys, Statistical tools
Responsibilities
Lead root cause analysis for product failures, Perform failure analysis using risk assessment tools, Lead cross-functional ideation of design solutions, Perform technical trends and consolidated investigations, Support evaluation of returned products and batch records, Generate final investigation reports, Manage and mentor staff
Seniority
Senior, hands-on IC with mentorship responsibilities