Senior Reliability Engineer, Medical Devices (Electromechanical)

Diality, Inc.; Irvine (CA); On-site; USD 138,000 - 155,000; Full time

Job summary

Diality, Inc. is seeking a Staff Reliability Engineer to lead the reliability architecture for advanced electromechanical and fluidic medical devices.

You will define and defend the end-to-end reliability program across the product lifecycle and collaborate with cross-functional teams to ensure regulatory compliance. You will drive FMEA, hazard analyses, design-for-reliability, HALT/ALT testing, and CLINICAL trial readiness.

Qualifications

• Experience with FDA QSR / 21 CFR 820 and ISO 13485 in medical devices.
• Proven ability to author DHF reliability deliverables for regulatory submissions (IDE/510(k)).
• Strong design-for-reliability and life-testing expertise.

Responsibilities

• Lead cross-functional teams through medical device design control.
• Drive FMEAs and hazard analyses linking to patient safety and device availability.
• Verify operating design margins, derating, and limits under worst-case conditions.
• Direct multi-phase life-cycle testing and wear-decay characterization to establish PM schedules.
• Architect and commission automated reliability test fixtures and data acquisition systems.
• Lead HALT and accelerated aging to uncover vulnerabilities.
• Oversee reliability activities for clinical trial readiness and transport/de-risking across configurations.
• Lead formal investigations and implement CAPAs using RCA methods.
• Use cloud analytics and defect tracking to monitor fleet health and alarm trends.

Skills

Regulatory standards

Design for Reliability

HALT/ALT

Weibull/MTBF

Root Cause Analysis

Project leadership

Education

Bachelor's degree in Biomedical/Mechanical/Electrical/Systems/Reliability Eng

Master's degree in Engineering

Tools

Minitab

ReliaSoft/Weibull++

JMP

Job description

Diality, Inc. is seeking a Staff Reliability Engineer to lead the reliability architecture for advanced electromechanical and fluidic medical devices.

You will define and defend the end-to-end reliability program across the product lifecycle and collaborate with cross-functional teams to ensure regulatory compliance. You will drive FMEA, hazard analyses, design-for-reliability, HALT/ALT testing, and CLINICAL trial readiness.