Sr. Project Engineer I, Lifecycle Engineering at iRhythm Technologies

California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare TechnologyIndustries

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

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)

Skills

Key technologies and capabilities for this role

Project ManagementLifecycle EngineeringMedical DevicesPLMGD&TBOM ManagementRisk ManagementProcess OptimizationSupplier ManagementDesign EnhancementsComplianceCross-Functional Leadership

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What are the key responsibilities for this Senior Project Engineer role?

You will lead lifecycle initiatives for released products, drive engineering changes through PLM, partner with supplier quality and operations for validations and improvements, coordinate integrations across design and manufacturing, maintain risk files per ISO 14971, and ensure regulatory compliance.

What is the company culture like at iRhythm?

iRhythm fosters a collaborative, innovative environment where employees collaborate, create, and reimagine possibilities, driven by a commitment to put patients first, think big, move fast, and improve lives through cardiac health solutions.

What makes a strong candidate for this role?

iRhythm is looking for curious and innovative problem solvers who are builders eager to lead cross-functional projects, champion cost reductions and process improvements using Lean/Six Sigma, and ensure compliance in a medical device lifecycle engineering environment.

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Mental Health Support

Hybrid Work Options

Pet Insurance

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.

FDA warning letter may lead to regulatory scrutiny and potential fines.

Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.

iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.

The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.

Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.

AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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