Senior Electrical Engineer: Medical Device Test & Reliability Lead

iRhythm Technologies, Inc.; California; On-site; USD 127,000 - 165,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Senior Electrical Engineer in Orange County, CA, to lead electrical investigations, develop test methods, and support manufacturing quality.

You will perform root cause analysis on PCBAs and medical device systems, drive CAPAs, and mentor technicians in a regulated, fast-paced environment. The role requires 8+ years in electrical engineering within regulated industries, strong diagnostic tooling expertise, and collaboration across Manufacturing, Quality,

Qualifications

• Bachelor’s degree in Electrical Engineering or a related discipline with 8+ years of experience in electrical engineering, manufacturing engineering, testing, validation, or failure analysis within a regulated industry.
• Demonstrated expertise in PCBA troubleshooting, root cause investigations, failure analysis, and electronic test system development.
• Experience supporting CAPA, nonconformance investigations, risk assessments, and Quality Management System compliance within regulated environments.
• Proficiency with electrical diagnostic equipment and data analysis tools used for product verification, debugging, and reliability investigations.

Responsibilities

• Lead electrical, functional, and failure analysis investigations across prototype, verification, validation, and production phases to ensure compliance with design, quality, and regulatory requirements.
• Perform root cause analysis and troubleshooting of PCBAs, electronic assemblies, and medical device systems related to manufacturing failures, reliability testing, nonconformances, customer complaints, and field returns.
• Develop, maintain, and improve electrical test methods, fixtures, automated test systems, and diagnostic processes to ensure accurate, repeatable, and traceable testing.
• Conduct board-level debugging and fault isolation using laboratory equipment including oscilloscopes, logic analyzers, digital multimeters, thermal imaging systems, and power analyzers.
• Identify electrical, component, manufacturing, and design-related failure mechanisms and drive effective corrective and preventive actions to improve product quality and reliability.
• Support disposition of nonconforming material through technical investigations and recommendations for rework, repair, containment, or scrap.
• Lead and support process validation (IQ/OQ/PQ) and test method validation activities for manufacturing and test systems.
• Participate in CAPA, nonconformance, complaint investigations, and risk assessments (FMEA) to identify root causes and implement corrective actions.
• Analyze manufacturing, reliability, and field performance data to identify trends, recurring failure modes, and opportunities for quality, yield, and reliability improvement.
• Collaborate with Manufacturing, Quality, Reliability, Supplier Quality, Operations, and Design Engineering teams to support product transfer, production readiness, and continuous improvement initiatives.
• Partner with suppliers, contract manufacturers, and external laboratories to support advanced failure analysis activities, including X-ray, cross-sectioning, microscopy, and material characterization.
• Develop and maintain SOPs, work instructions, and investigation procedures that support effective testing, troubleshooting, and manufacturing operations.
• Drive initiatives focused on test automation, process efficiency, defect reduction, yield improvement, and enhanced product reliability.
• Ensure compliance with FDA, ISO 13485, IEC 60601, and applicable Quality Management System requirements.
• Prepare clear, data-driven technical reports documenting investigation methods, findings, root cause conclusions, risk assessments, and corrective actions.
• Provide technical leadership and mentorship to engineers and technicians, promoting best practices in testing, troubleshooting, and failure analysis.
• Serve as the technical lead for complex cross-functional investigations involving manufacturing defects, supplier quality issues, reliability concerns, and field-returned products.

Skills

PCBA troubleshooting

Root cause analysis

Test system development

Process validation

Cross-functional collaboration

Quality management system

Data analysis

Technical leadership

Education

Bachelor's degree in Electrical Engineering

Tools

Oscilloscopes

Logic analyzers

Digital multimeters

Thermal imaging systems

Power analyzers

Job description

iRhythm Technologies, Inc. is seeking a Senior Electrical Engineer in Orange County, CA, to lead electrical investigations, develop test methods, and support manufacturing quality.

You will perform root cause analysis on PCBAs and medical device systems, drive CAPAs, and mentor technicians in a regulated, fast-paced environment. The role requires 8+ years in electrical engineering within regulated industries, strong diagnostic tooling expertise, and collaboration across Manufacturing, Quality,