Manager, Lifecycle Engineering at iRhythm Technologies

California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare TechnologyIndustries

Requirements

BS degree in Engineering (Mechanical, Electrical, Biomedical) or related technical field, Masters degree a plus
8+ years of experience in medical device engineering, with 2+ years’ experience managing an engineering team and/or being in a technical lead role (Class II/III environment preferred)
Ability to conceptualize and manage interactions between hardware, firmware, software, and mechanical components
Strong understanding of software development lifecycle (SDLC), testing methodologies, and quality assurance best practices
Strong understanding of FDA QSR, ISO 13485, IEC 60601, ISO 14971 and IEC 62304 standards
Demonstrated validation and problem-solving capability; hands-on root cause and CAPA execution for product and process issues
Proven experience in defining and executing SIT and UAT strategies across complex, integrated environments (e.g., MES, ERP, cloud platforms)
Experience & ability to navigate competing priorities and technical disagreements constructively
Proven technical writing skills, including managing specifications/requirements, developing, and maintaining design documentation

Responsibilities

Oversee lifecycle engineering projects maintaining product quality, compliance, and supply continuity across a diverse portfolio
Collaborate with cross-functional leaders to align on technical details, resourcing and timing of design and/or process implementation
Lead, develop and mentor a team of lifecycle engineers across various disciplines, providing mentorship and technical guidance supporting the product lifecycle engineering process
Define and implement product characterization methodologies and platforms to assess DFM and production readiness using SPC techniques (Cp, Cpk, CPU/CPL, GR&R)
Establish end-to-end System Integration Testing (SIT) and User Acceptance Testing (UAT) strategy across manufacturing, cloud platform, and enterprise platforms, with structured governance
Champion continuous improvement initiatives, leveraging Lean/Six Sigma methodologies to optimize processes and reduce costs
Lead root-cause investigations and CAPA implementation for product and process issues, ensuring timely closure and effectiveness verification
Drive engineering change control (ECO/DCO) processes, ensuring timely execution and adherence to design control requirements
Collaborate with Operations, Quality, and Regulatory to resolve manufacturing issues, improve yields, and support audits and inspections as required
Manage component obsolescence and supplier changes, including technical assessments, qualifications, and risk mitigation strategies
Ensures compliance with FDA QSR, ISO 13485, and ISO 14971, maintaining audit-ready DHF/DMR and risk management files

Skills

Key technologies and capabilities for this role

Lifecycle EngineeringMedical DevicesTeam LeadershipProject ManagementQuality ComplianceDFMSPCCpCpkGR&RSITUATProcess ImprovementSystem Integration TestingMentoring

Questions & Answers

Common questions about this position

What education is required for the Manager, Lifecycle Engineering role?

A BS degree in Engineering (Mechanical, Electrical, Biomedical) or related technical field is required, with a Masters degree preferred.

What experience level is needed for this position?

Candidates need 8+ years of experience.

What salary or compensation does this role offer?

This information is not specified in the job description.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What does the company culture at iRhythm look like?

iRhythm emphasizes collaboration, innovation, thinking big, moving fast, and putting patients first to improve lives.

What skills make a strong candidate for this role?

Strong candidates will have experience leading engineering teams, expertise in Lean/Six Sigma, SPC techniques, FDA QSR/ISO compliance, and managing lifecycle projects including root-cause analysis and obsolescence.

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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