Senior Sustaining System Engineer I

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:

The Senior Sustaining Engineer I will provide hands-on technical support for manufacturing of commercialized medical devices. This role is focused on troubleshooting, process optimization, and ensuring reliable, compliant production. The role is part of the system team within product development. The engineer will partner closely with manufacturing, quality, and R&D to resolve issues, implement improvements, and sustain product performance throughout its lifecycle.

Responsibilities:

• Manufacturing Support: Serve as the primary technical resource from Systems Engineering to troubleshoot equipment and process issues.
• Sustaining Engineering: Maintain and improve existing manufacturing tools to ensure quality, yield, and efficiency.
• Root Cause Analysis: Lead investigations for nonconformances, deviations, and customer complaints; develop and implement corrective and preventive actions (CAPA) with respect to manufacturing tools and fixtures.
• Change Management: Prepare and execute engineering changes for documentation, tools and fixtures.

• Continuous Improvement: Identify and implement cost-reduction, reliability, and efficiency improvements using Lean and Six Sigma methodologies.
• Documentation: Generate and maintain manufacturing documentation such as work instructions, validation protocols/reports, and risk assessments.
• Cross-Functional Collaboration: Work on design transfer activities with Quality/Supply Chain on sustaining production needs.
• Manage fixture vendors and coordinate internal programming resources to ensure delivery of the fixtures meet design requirements, on budget and on schedule.
• Drive integration and troubleshooting for complex, multi-component systems
• Define, execute and document system-level testing for Verification and Validation (V&V)
• Characterize process risks related to test fixture usage (PFMEA)
• Foster a close relationship with the Manufacturing team to develop a deep understanding of process, business and user needs (requires up to 30% travel)

Requirements:

• Bachelor's degree in Electrical, Biomedical, or a related field (Master's degree or higher preferred)
• 8 years of experience in sustaining or manufacturing engineering within the medical device industry (Class II or III preferred).
• Hands-on experience with process validation, equipment troubleshooting, and production support.
• Proficiency in root cause analysis tools (Fishbone, 5 Whys, FMEA) and statistical methods (SPC, DOE).
• Excellent technical writing and documentation skills.
• Ability to work independently on the production floor and collaborate across functions.
• Comfortable reading circuit board schematics and layout
• Familiarity with wireless (BLE, cellular, etc.) PCBA test systems a plus
• Efficient and effective communication and collaboration skills; ability to synthesize information clearly and convey to other engineers (electrical, mechanical, software, manufacturing, etc.)
• Experience with medium to high volume manufacturing process and automated test fixtures
• Prior experience in medical device development is highly desirable.

Work Arrangement

• Onsite role, based in our Cypress, California manufacturing and operations location

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

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 taops@irhythmtech.com

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 taops@irhythmtech.com. 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