Senior Sustaining Systems Engineer

Senior Sustaining Systems Engineer – iRhythm Technologies, Inc.

• 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 meets 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.
• 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.

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