Staff Reliability Engineer

Diality, Inc.; Irvine (CA); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

Medical device regulations

Reliability engineering

HALT/ALT testing

Root cause analysis

Educación

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

Master's degree in engineering

Descripción del empleo

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Staff Reliability Engineer serves as the technical authority and cross-functional engineering lead for the reliability architecture of advanced, complex electromechanical and fluidic medical device systems. In this role, you will define, execute, and defend the end-to-end reliability program across the complete product lifecycle.

Responsibilities

• Lead cross-functional engineering teams through the medical device design control process (FDA 21 CFR Part 820, ISO 13485), author and maintain critical DHF deliverables including Reliability Plans and Reliability Reports,
• Drive bottom-up component design FMEAs, system-level hazard analyses to map degradation mechanisms and failure modes directly to patient safety and device availability.
• Evaluate and verify operating design margins, electrical/electronic component derating (voltage, current, power, temperature), and mechanical/fluidic load limits under worst-case boundary conditions to eliminate latent failure mechanisms.
• Direct multi-phase life-cycle testing and wear-decay characterization on dynamic and components translate test outputs into baseline Preventive Maintenance (PM) schedules and service intervals.
• Architect and commission automated, multi-station reliability test fixtures, environmental test loops, and data acquisition systems. Manage internal testing operations and external accredited test laboratories to satisfy project milestones.
• Direct Highly Accelerated Life Testing (HALT) and system accelerated thermal aging to uncover electromechanical and structural vulnerabilities.
• Lead engineering reliability activities for clinical trial readiness, execute transportation and distribution de-risking across different shipping configurations.
• Lead formal engineering investigations into complex technical anomalies across hardware, software, fluidic, and sensor subsystems, apply structured problem-solving (8D, Fishbone, 5 Whys, FTA) to implement robust CAPAs and systematically design out legacy failure modes.
• Leverage connected cloud analytics platforms and defect tracking systems to monitor real-time fleet health, alarm trends, and Pareto failure metrics serve as technical reliability authority on cross-functional escalation boards.

Requirements

Required Skills & Abilities

• Expert knowledge and applied experience with medical device regulations and design standards, including FDA QSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62366-1 with proven track record of authoring DHF reliability deliverables for regulatory submissions (e.g., IDE, 510(k))
• In-depth technical expertise in Design for Reliability (DfR), Highly Accelerated Life Testing (HALT), Accelerated Life Testing (ALT), physics-of-failure, stress derating analysis, Weibull reliability modeling, and statistical MTBF demonstration at defined confidence intervals.
• Proficiency with statistical/reliability software (e.g., Minitab, ReliaSoft / Weibull++, JMP.
• Demonstrated leadership in executing Root Cause Analysis across multi-disciplinary engineering domains, proven capability in managing contract engineering resources, specialized test fixture fabricators, external test labs.

Education & Experience

• Bachelor’s degree in Biomedical, Mechanical, Electrical, Systems, or Reliability Engineering with a minimum of 8 years of related engineering experience, OR a Master’s degree in engineering with a minimum of 6 years of related engineering experience.
• Minimum 5+ years of direct experience in medical device development (Class II or Class III), with demonstrated expertise in complex electromechanical and dynamic fluidic/hydraulic systems

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Must be able to access all areas of the facility to determine needs

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.