Reliability Engineer - 258143

Medix™; Irvine (CA); On-site; USD 110,000 - 130,000; Full time

Job summary

Medix partners with a growing medical device company to recruit a Reliability Engineer in Irvine, CA. You will ensure safety, durability, and long-term performance of electromechanical devices throughout the product lifecycle and drive reliability requirements and test strategies.

You will collaborate with R&D, Design Quality, Manufacturing, Regulatory Affairs, suppliers, and external labs to plan and execute testing, investigate failures, and implement corrective actions, contributing to risk

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 5+ years of experience supporting electromechanical products.
• Experience planning or executing product reliability, lifecycle, environmental, or verification testing.
• Experience with failure analysis and root-cause investigation.
• Ability to develop technical protocols, test methods, and reports.
• Strong ability to interpret test data and present findings to stakeholders.
• Proficiency with Excel, Word, and PowerPoint.
• Strong organizational skills and ability to manage multiple priorities.
• Attention to detail and regulatory compliance.

Responsibilities

• Establish product reliability requirements and verification strategies for new and existing devices.
• Support Design for Reliability throughout development, transfer, and sustaining engineering.
• Plan and execute accelerated life, environmental, fatigue, and reliability testing.
• Develop and validate test methods, fixtures, protocols, acceptance criteria, and reports.
• Evaluate device performance under simulated shipping, storage, and clinical-use conditions.
• Investigate product failures using structured problem-solving methods.
• Recommend design or process improvements and verify corrective actions.
• Analyze reliability data using Weibull analysis and reliability-growth methods.
• Coordinate testing with internal teams and external laboratories.
• Collaborate on design verification, risk mitigation, and continuous improvement.
• Support ISO 14971 risk-management activities and DFMEA/PFMEA.

Skills

Data-driven problem-solving

Test data interpretation

Documentation

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office

Job description

Work Arrangement: Full-time, onsite Monday-Friday

Pay: $110K - 130K

Company Overview

Medix is partnered with a growing medical device company that develops handheld surgical-navigation technology for knee and hip replacement procedures. Its electromechanical devices provide surgeons with real-time measurements to support accurate bone preparation, implant positioning, leg-length restoration, and joint alignment. The company's portable technology offers hospitals and ambulatory surgery centers an alternative to larger robotic navigation systems.

Position Overview

The Reliability Engineer will ensure the safety, durability, accuracy, and long-term performance of electromechanical medical devices throughout the product lifecycle. This person will establish reliability requirements, develop test strategies, conduct product life and environmental testing, investigate failures, and use test data to recommend design and manufacturing improvements.

The engineer will support both new product development and existing commercial products, working closely with R&D, Design Quality, Manufacturing, Regulatory Affairs, suppliers, and external testing laboratories. This is a product-focused reliability position—not a facilities or maintenance reliability role.

Key Responsibilities

• Establish product reliability requirements and verification strategies for new and existing electromechanical medical devices.
• Support Design for Reliability throughout product development, design transfer, and sustaining engineering.
• Plan and execute accelerated life, accelerated aging, environmental, fatigue, and electromechanical reliability testing.
• Develop and validate test methods, fixtures, protocols, acceptance criteria, and final reports.
• Evaluate device performance under simulated shipping, storage, handling, and clinical-use conditions.
• Investigate product failures found during development, manufacturing, testing, or field use using tools such as 5 Whys, fishbone analysis, and fault-tree analysis.
• Recommend design, component, material, supplier, or manufacturing-process improvements and verify the effectiveness of corrective actions.
• Analyze reliability and product-life data using Weibull analysis, reliability-growth methods, and confidence intervals.
• Coordinate testing with internal teams and external laboratories.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs on design verification, risk mitigation, and continuous product improvement.
• Support ISO 14971 risk-management activities, including hazard analyses, DFMEA, PFMEA, and risk-control verification.
• Contribute to complaint investigations, CAPAs, nonconformances, and post-market surveillance.
• Maintain accurate reliability documentation in accordance with the medical device quality system.

Required Qualifications

• Bachelor's degree in engineering, electronics, biomedical engineering, mechanical engineering, electrical engineering, or a related technical discipline.
• At least five years of experience supporting electromechanical products.
• Experience planning or executing product reliability, lifecycle, environmental, or verification testing.
• Demonstrated experience with failure analysis, root-cause investigation, and data-driven problem-solving.
• Ability to develop technical protocols, test methods, engineering reports, and other controlled documentation.
• Strong ability to interpret test data and clearly present technical findings to cross-functional stakeholders.
• Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
• Strong organizational skills and the ability to manage multiple testing and investigation priorities.
• High attention to detail and commitment to product safety, documentation accuracy, and regulatory compliance.