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# Reliability Engineer

- **Company:** Orthalign Inc.
- **Location:** Irvine, CA, United States
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Software Documentation, Document Management Systems, Failure Mode Effects Analysis, Microsoft Office, Reliability Engineering, Software Reliability Testing, Requirements Management, Strategies of Testing, Reliability of Systems, Data Analytics
- **Published:** September 21, 2026
- **Apply:** https://www.careerbuilder.com/job-details/reliability-engineer-irvine-ca--af37a743-b068-4f1d-9e6b-cfad362632fc

## About the Role

A bachelors degree in engineering, electronics, or a related field of study Five years or more of experience in electromechanical products Experience with technical writing Strong proficiency with MS Office Suite Experience demonstrating a methodical approach to problem solving and data interpretation Ability to clearly convey technical information to cross-functional teams and stakeholders Ability to maintain high standards in documentation, testing, and analysis to ensure product safety and compliance Flexibility and strong organizational skills with ability to prioritize multiple tasks, Analysis Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Document Management, Documentation Standards, Electromechanics, Electronic Engineering, Establish Priorities, Hazard Analysis, ISO (International Organization for Standardization), Laboratory, Manufacturing, Manufacturing Requirements, Medical Equipment, Medical Products, Microsoft Office, Multitasking, Organizational Skills, Problem Solving Skills, Process Improvement, Product Design, Product Development, Product Lifecycle, Product Safety, Product Support, Quality Assurance Methodology, Reliability Analysis, Reliability Engineering, Reliability Testing, Requirements Management, Requirements Validation/Verification, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Root Cause Analysis, Safety Compliance, Safety/Work Safety, Statistics, Support Documentation, Surveillance, Technical Writing, Test
Equipment, Test Fixtures, Test Lab, Test Plan/Schedule, Testing, Validation Testing, Writing Skills

## Description

You must have the ability to report daily to our headquarters in Irvine, California.

You Will:

Develop product reliability requirements and reliability verification strategies for new and sustaining medical device products. Support Design for Reliability (DfR) activities throughout product development and design transfer. Plan and execute reliability studies including accelerated life testing, accelerated aging, environmental testing, fatigue testing, and electromechanical reliability evaluations. Develop and validate reliability test methods and test protocols. Collaborate closely with R & D, Design Quality, Manufacturing, and Regulatory Affairs to identify and mitigate reliability risks throughout the product lifecycle. Support reliability growth activities through data-driven design improvements and verification testing. Develop reliability test protocols and report supporting design verification and validation activities. Perform statistical life-data analysis using Weibull analysis, reliability growth methods, and confidence interval calculations. Investigate product failures
occurring during development, manufacturing, and field use. Conduct root cause investigations utilizing structured problem-solving techniques including 5 Whys, Fishbone Analysis, and Fault Tree Analysis. Coordinate reliability testing activities with internal and external laboratories. Support development of fixtures, test equipment, and test methodologies required to characterize long-term product reliabililty. Support ISO 14971 risk management activities including hazard analysis, DFMEA, PPFMEA, and risk-control verification. Support complaint investigations, CAPA activities, and post-market surveillance initiatives. Maintain reliability documentation and support controlled document revision activities in accordance with the quality system.


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