Senior Medical Device Reliability Engineer

Diality, Inc.; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

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

You will define, execute, and defend end-to-end reliability programs across the full product lifecycle, ensuring patient safety and device availability. Responsibilities include designing DHF deliverables, performing FMEAs and hazard analyses, coordinating HALT/ALT testing, and deploying cloud analytics for fleet health monitoring.

Qualifications

• Experience with FDA QSR / 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62366-1
• Expertise in design for reliability, HALT/ALT, physics-of-failure, and Weibull modeling
• Proven ability to lead cross-functional teams and manage external test labs.

Responsibilities

• Lead reliability program across the complete product lifecycle under FDA/ISO
• Develop and defend DHF deliverables and reliability reports for regulatory submissions
• Oversee multi-phase life-cycle testing, MTBF estimation, and preventive maintenance planning
• Architect and manage test fixtures, environmental loops, and data acquisition
• Coordinate internal testing and external accredited labs to meet milestones

Skills

Medical device regulations

Reliability engineering

HALT/ALT testing

Root cause analysis

Education

Bachelor's degree in Biomedical/Mechanical/Electrical/Systems or Reliability Engineering

Master's degree in engineering

Job description

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

You will define, execute, and defend end-to-end reliability programs across the full product lifecycle, ensuring patient safety and device availability. Responsibilities include designing DHF deliverables, performing FMEAs and hazard analyses, coordinating HALT/ALT testing, and deploying cloud analytics for fleet health monitoring.