Staff Reliability Engineer

Job Description

Job Description

Role: Reliability Engineer II
Type: Full-Time Contract (1 year)
Compensation: Starting at $51 per hour, commensurate with experience
Location: Onsite – Central Orange County

Position Description:

The Reliability Engineer II will execute reliability engineering activities across the product lifecycle for electrophysiology (EP) catheters, accessories, and capital equipment, from development through verification, design transfer, commercialization, and post-market. Working with senior and staff reliability engineers, you’ll own reliability tests and analyses for assigned products, investigate failures, and turn data into well-supported design and process improvements.

This isn’t just a test-execution role. You’ll connect product risks and physical failure mechanisms to measurable requirements and statistically sound evidence, and partner with R&D, Systems Engineering, Quality, Manufacturing, Supplier Quality, and Post-Market teams to drive improvements.

Responsibilities:

• Execute elements of Reliability Program Plans for EP catheters, accessories, and capital equipment, including reliability requirements, test plans, and reports.
• Design and run reliability tests independently, including characterization, test-to-failure, accelerated life testing, degradation, and accelerated aging studies.
• Perform reliability and statistical analyses, including Weibull analysis with censored data, B-life estimates, confidence bounds, sample-size justification, and DOE.
• Contribute to and help facilitate FMEA/FMECA, fault tree analyses, and design reviews, applying design-for-reliability principles such as design margins and derating.
• Investigate failures through FRACAS: gather lab, manufacturing, supplier, complaint, and field data, perform root cause analysis, and verify corrective actions.
• Evaluate catheter failure mechanisms such as articulation, torque, flex, fatigue, bonds, insulation, sterilization, aging, and simulated use.
• Support capital equipment reliability assessments across electronics, PCB assemblies, power supplies, sensors, pumps, motors, and cables, including MTBF and reliability prediction.
• Author test protocols, reports, and technical documentation in compliance with design controls and quality system requirements.
• Present test results, risks, and recommendations to engineering teams; support and train associate engineers and technicians.

Required Qualifications:

• Bachelor’s degree in Biomedical, Mechanical, Electrical, Computer, Systems, Reliability, Materials, Mechatronics, Aerospace, or a related engineering discipline.
• 2–4 years of experience in reliability, test, quality, or product development engineering in a regulated or safety-critical industry (medical device, aerospace, automotive, defense, or similar).
• Hands-on experience planning and executing reliability or life tests and analyzing the results.
• Working knowledge of reliability statistics, including Weibull analysis, confidence intervals, and sample-size determination.
• Experience with FMEA and root cause analysis methods.
• Proficiency with statistical tools such as Minitab or JMP.
• Strong technical writing and communication skills.

Preferred Qualifications:

• Medical device experience, especially cardiovascular, electrophysiology, catheter-based devices, or electromechanical capital equipment.
• Experience with ReliaSoft (Weibull++, ALTA, BlockSim, RGA, or Lambda Predict) or similar reliability software.
• Exposure to HALT/HASS, accelerated aging, reliability growth, or FRACAS processes.
• Familiarity with design controls, risk management (ISO 14971), and FDA quality system regulations.
• Programming experience in Python, R, or MATLAB.
• Certified Reliability Engineer (CRE), Six Sigma certification, or progress toward either.