What are the responsibilities and job description for the Staff / Principal Reliability Engineer position at InterSources Inc?
Staff / Principal Reliability Engineer
Location: San Jose, CA
Job Type: Full-Time
Experience: 10 Years
Job Overview
We are seeking a highly experienced Staff / Principal Reliability Engineer to lead reliability strategy, testing, and validation for complex electromechanical medical devices and capital equipment systems. This role requires deep expertise in reliability engineering, accelerated life testing, predictive analysis, and regulated product development environments.
Key Responsibilities
• Lead system-level reliability engineering activities for complex electromechanical and embedded systems.
• Design and execute reliability testing including ALT, HALT/HASS, environmental, and stress testing.
• Perform reliability analysis including MTBF calculations, Weibull analysis, Fault Tree Analysis (FTA), and reliability growth modeling.
• Develop reliability requirements, test plans, protocols, and reports for NPI and sustaining engineering programs.
• Analyze field failures, complaint trends, and nonconformance data to drive product improvements and root cause investigations.
• Collaborate with R&D, Systems Engineering, Manufacturing, Quality, and Regulatory teams.
• Develop and maintain automated testing frameworks using Python and C .
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable regulatory standards.
Required Qualifications
• Bachelor’s or Master’s degree in Mechanical, Electrical, Biomedical Engineering, or related field.
• 10 years of hands-on engineering experience with increasing technical leadership responsibilities.
• 5 years of reliability engineering experience in Medical Devices, Aerospace, Automotive, or other highly regulated industries.
• Strong experience with:
o Capital Equipment / Complex Electromechanical Systems
o ALT / HALT / HASS Testing
o MTBF & Weibull Analysis
o Reliability Prediction Models (MIL-HDBK-217, Telcordia, FIDES)
o Root Cause Analysis
o Python & C Automation
• Strong analytical, troubleshooting, and communication skills.
Preferred Qualifications
• ASQ CRE or CQE Certification
• Experience with robotic medical systems
• Experience with automated test infrastructure and manufacturing environments