Reliability Engineer II
Core
Execute complex failure analysis investigations on returned medical device products (readers and sensors) and maintain programs for systematic monitoring of product reliability and quality standards.
Role type
Senior IC reliability engineer (medical devices)
Builds
Medical device readers and sensors for diabetes management
Domain
Healthcare / Medical Devices / Electrical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
product failure analysis, hardware/software integration, reliability investigations, CAPA activities, embedded systems knowledge, electrical design principles, project management, technical writing
Preferred skills
FDA Quality System Regulations (21 CFR Part 820), ISO 13485, data analysis and statistical tools (Power BI, Python), Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA)
Technologies
Power BI, Python
Responsibilities
Perform detailed failure analysis on returned ADC products including hardware and embedded software components, lead and support medium-sized projects applying project management methodologies, collaborate with cross-functional teams to address recurring reliability issues, conduct sustaining activities such as process improvements and tooling updates, apply quality principles to analyze quality records and reports, document reliability issues and performance measures for management review, provide technical guidance to engineers and mentor on best practices, liaise with external vendors and internal design teams to resolve technical challenges
Seniority
Senior, hands-on IC
