Sr. Electronics Engineer

irhythmtech; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

iRhythm is seeking a Senior Electrical Engineer with deep expertise in electrical testing, failure analysis, and manufacturing support within a regulated medical device environment. The role leads complex investigations, develops test methods, and drives product quality improvements while collaborating across functions.

The ideal candidate will have strong PCBA troubleshooting, root cause analysis, and experience with test system development and process validation, ensuring compliance with QMS

Qualifications

• Bachelor's degree in Electrical Engineering or related discipline.
• 8+ years of experience in electrical engineering, manufacturing engineering, testing, validation, or failure analysis within a regulated industry.
• Experience with CAPA, nonconformance investigations, risk assessments, and QMS in regulated environments.

Responsibilities

• Lead investigations across prototype, verification, validation, and production to ensure design, quality, and regulatory compliance.
• Perform root cause analysis and troubleshooting of PCBA and electronic assemblies.
• Develop and maintain electrical test methods, fixtures, automated test systems, and diagnostics.
• Conduct board-level debugging using oscilloscopes, logic analyzers, DMMs, and thermal imaging.
• Identify failure mechanisms and drive corrective/preventive actions.
• Support disposition of nonconforming material with recommended rework or scrap.
• Lead process validation and test-method validation for manufacturing and test systems.
• Participate in CAPA, nonconformance, and risk assessments to identify root causes and actions.
• Analyze data to identify trends and opportunities for quality improvements.

Skills

PCBA troubleshooting

Root cause analysis

Test system development

Process validation

Cross-functional collaboration

Electrical testing

Data analysis

Education

Bachelor's degree in Electrical Engineering or related discipline

Tools

Oscilloscopes

Logic analyzers

Digital multimeters

Thermal imaging systems

Power analyzers

X-ray

Cross-sectioning

Microscopy

Job description

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role

iRhythm is seeking a Senior Electrical Engineer with extensive experience in electrical testing, failure analysis, manufacturing support, and quality-driven problem solving within a regulated medical device environment. This role is responsible for leading complex investigations, developing and validating test methods, supporting manufacturing operations, and driving product quality and reliability improvements. The ideal candidate possesses strong expertise in PCBA troubleshooting, root cause analysis, test system development, process validation, and cross-functional collaboration within a Quality Management System (QMS).

Essential Duties and 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.

Experience and Minimum 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.
• Strong technical leadership, communication, and cross-functional collaboration skills with the ability to drive investigations from problem identification through corrective