Senior Sustaining System Engineer

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

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.

• 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)

• Bachelor's degree in Electrical, Biomedical, or a related field (Master's degree or higher preferred)
• Minimum 5 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.

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

Orange County

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

$ - $

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…