Engineer - Complaints Technical Investigator
Core
Conduct forensic evaluations of returned medical device units to identify root causes of product complaints and design failures.
Role type
Senior IC failure analysis engineer (medical devices)
Builds
Structured failure analysis processes, test methods, and business plans for product improvements
Domain
Biotechnology / Medical Devices
Required skills
Root cause analysis, failure mode identification, risk assessment (FMEA, Fault Tree), statistical analysis, protocol writing, SOP development, equipment setup and validation
Preferred skills
Six Sigma proficiency, ISO 14971 risk management, design of experiments, continuous improvement leadership, technical writing
Technologies
CT scanners, Instron tensile test machines, SEM, fishbone diagrams, 5 Whys
Responsibilities
Lead evaluation of returned products and batch records; Perform failure analysis using advanced equipment; Lead cross-functional ideation for design solutions; Generate final reports with data analysis; Develop and validate test methods and SOPs
Seniority
Senior, hands-on IC
