Compensation:
Starting at $54 per hour will commensurate with experience
Location:
Onsite – Central Orange County
Length of Contract:
1 year
Position Description:
The Reliability Engineer will define and execute advanced reliability strategies across the product lifecycle, from concept and architecture through verification, design transfer, commercialization, and post-market learning. This role combines hands‑on technical depth with cross‑functional leadership and will partner with R&D, Systems Engineering, Quality, Manufacturing, Supplier Quality, Regulatory, Risk Management, Service, Complaints and CAPA teams.
This is not solely a verification-testing role. The successful candidate will translate clinical use, product risks and physical failure mechanisms into measurable requirements, robust designs, statistically defensible evidence and verified improvements.
Responsibilities:
- Lead Reliability Program Plans for EP catheters, reusable accessories, capital equipment, and integrated systems throughout the product lifecycle.
- Integrate RAMS and Design for Reliability into new product development using mission profiles, reliability requirements, Physics of Failure, FMEA/FMECA, fault trees, reliability block diagrams, design margins, and derating.
- Develop risk-based reliability test strategies, including characterization, test-to-failure, accelerated life testing, degradation testing, reliability growth, and reliability demonstration.
- Perform advanced reliability and statistical analyses, including Weibull analysis, censored data, B-life, confidence bounds, sample-size justification, DOE, repairable-system analysis, MTBF, MTTR, and availability.
- Lead FRACAS investigations and translate laboratory, manufacturing, supplier, complaint, service, CAPA, and field data into verified design and process improvements.
- Evaluate catheter failure mechanisms, including articulation, torque, flex, fatigue, bonds, insulation, signal integrity, irrigation, materials, aging, sterilization, and simulated use.
- Assess capital-equipment reliability across electronics, PCB assemblies, power supplies, sensors, pumps, motors, cables, communications, embedded software, diagnostics, and serviceability; apply FIDES or other appropriate component reliability-prediction methods.
- Mentor engineers, review complex reliability analyses, and communicate technical risks, uncertainties, and recommendations to engineering teams and leadership.
Required Qualifications:
- Bachelor's in Biomedical, Mechanical, Electrical, Computer, Systems, Reliability, Materials, Mechatronics, Aerospace, or a related engineering discipline, with experience commensurate with education level.
- Demonstrated expertise in RAMS, Design for Reliability, Reliability Program Planning, Physics of Failure, FRACAS, reliability statistics, and reliability test strategy.
- Experience supporting New Product Development, design controls, risk management, verification and validation, design transfer, and sustaining engineering.
- Experience with complex mechanical, electrical, electromechanical, or software-enabled products in regulated, safety-critical, or mission-critical industries.
- Proficiency with ReliaSoft or equivalent reliability engineering software and statistical tools such as Minitab, JMP, or SPSS.
Preferred Qualifications:
- Medical-device experience preferred, particularly in cardiovascular, electrophysiology, catheter-based devices, and surgical capital equipment, including disposable products and repairable capital equipment.
- Advanced ReliaSoft experience (Weibull++, ALTA, BlockSim, RGA, or Lambda Predict), with knowledge of FIDES, HALT/HASS, accelerated aging, supplier reliability, complaint/CAPA investigations, or Reliability-Centered Maintenance.
- Programming experience in Python, R, or MATLAB preferred; Certified Reliability Engineer (CRE) or Six Sigma certification is a plus.