The posting
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 action implementation.
Knowledge, Skills and Abilities
- Advanced knowledge of electronic circuits, PCBA manufacturing processes, failure mechanisms, and medical device quality systems.
- Expertise in board-level debugging, failure analysis, and structured root cause investigation methodologies.
- Knowledge of Design for Manufacturability & Testability (DFM/DFT) principles to PCBA design influencing component selection, footprints, panelization, layout, and test strategy in partnership with Product Development teams to reduce yield loss, rework, and time to volume production.
- Proficiency with laboratory instrumentation, including oscilloscopes, logic analyzers, digital multimeters, thermal imaging systems, and automated test equipment.
- Ability to analyze data, assess product risk, identify trends, and implement effective corrective and preventive actions.
- Strong technical communication, documentation, leadership, and mentoring skills with the ability to effectively present investigation findings to cross-functional stakeholders.
Work Environment / Other Requirements
iRhythm offers a fast-paced, collaborative environment focused on delivering innovative solutions that improve patient outcomes and advance cardiac care. This role works closely with Manufacturing, Quality, Operations, Software, and Supplier partners to solve complex technical challenges and drive continuous improvement. The ideal candidate thrives in a hands-on, data-driven environment, effectively manages multiple priorities, and is passionate about product quality, reliability, and patient safety.
#LI-onsite #LI-LM1
Location:
Orange County
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$127,000.00 - $165,000.00
As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]
About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
