Sr. Project Engineer I, Lifecycle Engineering

Career-defining. Life-changing.

At iRhythm youll 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 whats 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:

iRhythms Product Development team is seeking a highly skilled Senior Project Engineer I to join our Lifecycle (Sustaining) Engineering team. This role focuses on supporting existing products through their lifecycle ensuring quality compliance and continuous improvement while maintaining business this role you will have the opportunity to lead cross-functional projects that keep released medical device products compliant reliable cost-effective and continuously manufacturable. Youll play a pivotal role within iRhythms Lifecycle Engineering (LCE) Center of Excellence charting the course for the companys capabilities and collaborating with cross-functional teams. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

What You Will Be Doing

• Lead (project & technical) lifecycle initiatives across a portfolio of released products to preserve quality supply continuity cost and compliance; own charters integrated plans schedules budgets and risk registers.
• Champion initiatives to reduce cost and improve delivery performance through design enhancements process optimization and supplier engagement.
• Drive engineering changes through PLM including requirements updates BOM and drawing revisions (GD&T) tolerance analyses and complete DHF/DMR impacts under design control.
• Partner with supplier quality to review supplier changes and obsolescence including technical assessments qualifications/first article PPAP (as applicable) alternate materials/components and SCAR collaboration.
• Partner with Operations to plan and execute line validations (IQ/OQ/PQ) and identify opportunities to improve yields reduce scrap/cycle time and stabilize processes using Lean/Six Sigma and evidence-based decision making.
• Coordinate integration of PCBA firmware mechanical design and test systems between product development and manufacturing
• Coordinate across testing initiatives for system integration (SIT) UAT across manufacturing cloud and enterprise platforms (E2E testing)
• Maintain and update risk management files per ISO 14971 (pFMEA/dFMEA hazard analyses) with inputs from post-market surveillance complaints and nonconformances.
• Ensure regulatory and QMS compliance (21 CFR 820/ISO 13485) including change impact assessments for submissions labeling/UDI implications and support for audits/inspections.
• Own clear communication and stakeholder alignment providing status metrics and decisions to leadership; mentor junior engineers and reinforce Good Documentation Practices (GDP).

What We Want To See

• BS degree in Engineering (Mechanical Biomedical Electrical or related technical field).
• 5 years of engineering experience in medical device manufacturing or sustaining engineering (Class II/III environment preferred).

• Strong understanding of FDA QSR/QMSR ISO 13485 ISO 14971 and design controls
• Proven management of ECO/change control in PLM
• Demonstrated validation and problem-solving capability: IQ/OQ/PQ MSA SPC/DOE; hands-on root cause (8D/DMAIC) and CAPA execution for product and process issues.
• Demonstrated use of SQDC (Safety Quality Delivery Cost) metrics to drive continuous improvement and operational excellence in lifecycle engineering activities a plus.
• Knowledge of test fixture development process validation and manufacturing workflows
• Ability to conceptualize and manage interactions between hardware firmware software and mechanical components
• Ability to navigate competing priorities and technical disagreements constructively.
• MS office suite including Project/Smartsheet

Ways To Stand Out

• PMP (or formal project management training) and/or Agile exposure for cross-functional execution a plus.
• Lean/Six Sigma certification (Green or Black Belt) a plus.
• Tool proficiency: CAD (e.g. SolidWorks or equivalent)

Work Environment / Other Requirements

• Location: On-site (Cypress CA Orange County)
• Up to 10% travel to iSF (San Francisco facility)

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

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 iRhythms 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 @ email address. Please check any communications to be sure they come directly from @ 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 Written offers of employment will be extended in a formal offer letter from an @ email address ONLY.

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Senior IC