Sr. Reliability Engineer - Hardware / Electrical
Core
Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs for the Affera HW system.
Role type
Senior Reliability Engineer (Hardware/Electrical)
Builds
Released product engineering and next generation ablation generator development for cardiac arrhythmia treatment systems.
Domain
Medical Device / Cardiac Ablation Solutions
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Reliability engineering, Design of Experiments (DOE), Statistical process control, Risk analysis, Mathematical modeling, Environmental testing specification, Corrective action management
Preferred skills
Design controls, V&V, Risk Management, System-thinking, Process mapping, 21CFR820, ISO13485, ISO14971, Medical Device experience, Electrical/Electronic experience
Technologies
None explicitly listed
Responsibilities
Develops and coordinates technical reliability studies and evaluations of engineering design concepts; Recommends design or test methods and statistical process control procedures; Completes risk analysis studies of new design and processes; Compiles and analyzes performance reports and process control statistics; Ensures corrective measures meet acceptable reliability standards; Analyzes preliminary plans and develops reliability engineering programs; May develop mathematical models to identify units or processes posing excessive failure risks; Proposes changes in design or formulation to improve system reliability; Determines units/batches requiring environmental testing and specifies sample sizes.
Seniority
Senior, hands-on IC