Principal Reliability Engineer - Hardware / Electrical
Core
Lead a small team of engineers to develop and qualify new medical device products with enhanced signal and power capabilities, prioritizing First-In Human feasibility studies.
Role type
Principal Reliability Engineer (Hardware/Electrical)
Builds
Next-Gen Affera Capital medical devices
Domain
Healthcare technology / Medical devices
Deliverable
production ML models | product features
Required skills
Reliability engineering, Design of Experiments (DOE), Risk analysis, Statistical process control, Mathematical modeling, Environmental testing planning, Corrective action management
Preferred skills
Electrical or Electronics engineering background, Product Development experience, Clinical/Feasibility project engineering, DV and Risk Management, Quality Core Team Member (QCTM) experience
Technologies
Statistical process control tools, DOE constructs
Responsibilities
Develop and coordinate technical reliability studies and evaluations of engineering design concepts; Recommend design or test methods and statistical process control procedures; Complete risk analysis studies of new design and processes; Analyze performance reports and process control statistics; Ensure corrective measures meet acceptable reliability standards; Develop reliability engineering programs to achieve company, customer, and governmental agency objectives; Propose changes in design or formulation to improve system and/or process reliability; Determine units and/or batches requiring environmental testing and specify sample sizes.
Seniority
Principal, hands-on IC with team leadership