Senior Design Lead - Reliability Analysis (MTBF)

Sapsf; United States; On-site; USD 140,000 - 210,000; Full time

Job summary

Sapsf seeks a Senior Design Lead - Reliability Analysis (MTBF) to drive reliability programs across EP catheters, reusable accessories, capital equipment, and integrated medical device systems. You will lead RAMS planning, Design for Reliability, FMEA/FMECA, FRACAS, reliability testing, Weibull analysis, and life-data studies, collaborating with cross-functional teams to deliver data-driven improvements.

You will mentor engineers, communicate risks to leadership, and push continuous improvement

Qualifications

• Experience leading reliability programs for complex medical devices.
• Deep knowledge of RAMS, DfR, FMEA/FMECA, FRACAS, and PoF analyses.
• Hands-on reliability testing and statistics with data-driven decision making.

Responsibilities

• Lead Reliability Program Plans across catheters, accessories, and equipment.
• Develop and execute reliability test strategies and conduct life-data analyses.
• Mentor engineers and communicate risks and recommendations to leadership.

Skills

Reliability Engineering

RAMS

DfR

FMEA/FMECA

FRACAS

Weibull analysis

ALT/HALT

Statistical analysis

ReliaSoft

Python

FDA compliance

Tools

ReliaSoft

Minitab

JMP

SPSS

Job description

Career Opportunities: Senior Design Lead - Reliability Analysis (MTBF) (180179)

Requisition ID180179-Posted10/14/2026

Lead reliability engineering activities for EP catheters, reusable accessories, capital equipment, and integrated medical device systems. Responsible for Reliability Program Planning, RAMS, Design for Reliability, FMEA/FMECA, FRACAS, reliability testing, Weibull analysis, accelerated life testing, failure investigation, risk management, and reliability growth. Collaborate with cross-functional teams to improve product reliability, support new product development, and ensure robust, maintainable medical devices through data-driven reliability strategies and continuous improvement initiatives.

Key Responsibilities

Lead Reliability Program Plans for EP catheters, reusable accessories, capital equipment, and integrated systems.Apply RAMS (Reliability, Availability, Maintainability & Safety) and Design for Reliability principles in new product development.Develop and execute reliability test strategies, including accelerated life testing, test-to-failure, degradation testing, and reliability demonstration.Perform reliability analyses such as Weibull analysis, MTBF, MTTR, availability analysis, DOE, and life-data analysis.Conduct FMEA/FMECA, fault tree analysis, reliability block diagrams, and Physics of Failure assessments.Lead FRACAS activities and drive corrective actions using field, complaint, manufacturing, supplier, and service data.Evaluate reliability of catheter components, including articulation, torque, flex, fatigue, insulation, materials, sterilization, and simulated-use performance.Assess reliability of capital equipment involving electronics, PCB assemblies, sensors, motors, pumps, embedded software, and communications systems.Utilize ReliaSoft and statistical tools to analyze reliability data and predict product performance.Support risk management, design verification & validation (V&V), design transfer, and sustaining engineering activities.Mentor engineers and communicate reliability risks, findings, and recommendations to cross-functional teams and leadership.Drive continuous improvement initiatives to enhance product reliability, quality, and patient safety.

Skill Requirements

Strong experience in Reliability Engineering, RAMS (Reliability, Availability, Maintainability & Safety), and Design for Reliability (DfR).Expertise in FMEA/FMECA, FRACAS, Fault Tree Analysis (FTA), Reliability Block Diagrams (RBD), and Physics of Failure (PoF).Hands-on experience with reliability testing, including Accelerated Life Testing (ALT), HALT/HASS, Test-to-Failure, and Reliability Demonstration Testing.Proficiency in reliability statistics and data analysis, including Weibull analysis, MTBF, MTTR, B-life, confidence intervals, and DOE.Experience with ReliaSoft tools (Weibull++, ALTA, BlockSim, RGA, Lambda Predict) and statistical software such as Minitab, JMP, or SPSS.Knowledge of risk management, design controls, verification & validation (V&V), design transfer, and sustaining engineering practices.Experience with medical devices, electromechanical systems, capital equipment, or other safety-critical products.Strong understanding of electrical, mechanical, software, and system-level reliability concepts.Familiarity with CAPA, complaint investigations, supplier quality, and reliability improvement methodologies.Programming or analytical skills in Python, R, or MATLAB are preferred.Excellent technical documentation, communication, problem-solving, and cross-functional collaboration skills.Knowledge of FDA-regulated medical device development and related quality standards is highly preferred.