Sr. Project Engineer I, Lifecycle Engineering

iRhythm•Orange County, CA

10d•$112,000 - $145,000•Hybrid

About The Position

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’s 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 continuity. In 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. You'll play a pivotal role within iRhythm's Lifecycle Engineering (LCE) Center of Excellence, charting the course for the company's capabilities, and collaborating with cross-functional teams. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

Requirements

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.

Nice To Haves

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)

Responsibilities

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).