Lead Reliability Engineer – Medical Devices

RCM Technologies, Inc.; Irvine (CA); In loco; USD 61.000 - 87.000; Tempo pieno

Descrizione del lavoro

RCM Technologies, Inc. is seeking a Reliability Engineer to define and execute reliability strategies across the product lifecycle, collaborating with R&D, Quality, Manufacturing, and CAPA teams.

The role combines hands-on technical depth with cross-functional leadership to translate risks and failure mechanisms into measurable requirements and robust designs, leading FRACAS and risk-based testing efforts.

Competenze

• Experience with RAMS, Design for Reliability, Reliability Program Planning, Physics of Failure, FRACAS, reliability statistics, and reliability test strategy.
• Experience with 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.

Mansioni

• 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.

Conoscenze

RAMS

Design for Reliability

Reliability Program Planning

Physics of Failure

FRACAS

Reliability statistics

Reliability test strategy

ReliaSoft

Minitab

JMP

SPSS

Formazione

Bachelor's in Biomedical, Mechanical, Electrical, Computer, Systems, Reliability, Materials, Mechatronics, Aerospace, or related engineering

Descrizione del lavoro

RCM Technologies, Inc. is seeking a Reliability Engineer to define and execute reliability strategies across the product lifecycle, collaborating with R&D, Quality, Manufacturing, and CAPA teams.

The role combines hands-on technical depth with cross-functional leadership to translate risks and failure mechanisms into measurable requirements and robust designs, leading FRACAS and risk-based testing efforts.