Senior Medical Device Reliability Lead

Aviso, LLC; Fremont (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Aviso, LLC is seeking a Reliability Quality Engineer to ensure the reliability and quality of a next-generation medical device ecosystem. You will lead system-level testing, develop reliability protocols, and collaborate with R&D, Manufacturing, and Quality to launch robust products.

You will apply advanced reliability tools (Weibull, fault tree, ALT/HASS) and perform data-driven analyses to guide design decisions, while ensuring compliance with ISO 13485 and FDA 21 CFR 820.

Qualifications

• Bachelor’s or Master’s degree in Engineering with relevant discipline.
• 5+ years of medical device industry reliability experience.
• Experience with ALT, HALT/HASS and reliability verification strategies.
• Ability to perform reliability prediction analyses using MIL-HDBK-217, Telcordia, and FIDES.
• Experience maintaining automated testing frameworks using Python and C++.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Lead system-level reliability strategy and testing for complex medical devices.
• Use Weibull analysis, reliability modeling, fault tree analysis, ALT, HALT/HASS.
• Define reliability requirements and test protocols for NPI and sustaining design changes.
• Design and execute reliability tests for mechanical, electrical, environmental, and software subsystems.
• Partner with R&D, Manufacturing, and Quality to link design requirements with risk management and verification.
• Analyze field data and nonconformance to drive product improvements.
• Develop reliability testing infrastructure and automation.
• Ensure compliance with ISO 13485 and FDA 21 CFR 820.
• Follow EHS policies.

Skills

Reliability engineering

Data analysis

Root cause analysis

Statistical methods

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical)

Tools

Python

C++

Job description

Aviso, LLC is seeking a Reliability Quality Engineer to ensure the reliability and quality of a next-generation medical device ecosystem. You will lead system-level testing, develop reliability protocols, and collaborate with R&D, Manufacturing, and Quality to launch robust products.

You will apply advanced reliability tools (Weibull, fault tree, ALT/HASS) and perform data-driven analyses to guide design decisions, while ensuring compliance with ISO 13485 and FDA 21 CFR 820.