Sr Staff Reliability Engineer

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

Position Overview

An innovative and growing medical technology company is seeking a Reliability Quality Engineer to ensure the product reliability and quality of a complex, next-generation medical device ecosystem. In this permanent, full-time role, you will develop and execute product reliability test plans and verification procedures based on design specifications. You will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable, advanced medical systems are designed, verified, and launched successfully.

What Your Day-to-Day Will Involve

Lead System-Level Reliability: Drive reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle.

Apply Advanced Methodologies: Utilize reliability engineering tools such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, Accelerated Life Testing (ALT), HALT/HASS, and structured root cause analysis to drive data-based design decisions.

Define Requirements: Establish reliability requirements, reliability growth plans, and demonstration strategies for NPI (New Product Introduction) programs and sustaining design changes; devise test protocols and author comprehensive test reports.

Execute Testing: Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.

Cross-Functional Partnership: Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.

Analyze Field Data: Drive reliability insights through the analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.

Collaborate on Robustness: Work alongside R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues.

Build Infrastructure: Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups.

Champion Culture: Foster a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis.

Maintain Compliance: Ensure alignment with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards.

EHS Alignment: Understand and adhere to standard corporate Environmental Health and Safety (EHS) policies.

Qualifications (Required)

Education: Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Electrical, or Mechanical).

Experience: 5+ years of experience in the medical device industry (or an equivalent regulated industry) demonstrating dedicated reliability expertise.

Technical Domain: Strong background working with Capital Equipment, complex electromechanical systems, and embedded software devices.

Testing Expertise: Proven experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.

Predictive Analysis: Experience performing reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.

Software Skills: Ability to maintain automated testing frameworks using Python and C++ to execute tests.

Soft Skills: Strong analytical, problem-solving, and statistical analysis skills, with the communication clarity needed to influence cross-functional engineering teams.

Qualifications (Preferred)

ASQ CQE (Certified Quality Engineer) or CRE (Certified Reliability Engineer) certification.

Basic machine tool and manufacturing experience.