iRhythm Technologies, Inc.
Manager, Lifecycle Engineering
iRhythm Technologies, Inc., California, Missouri, United States, 65018
Manager, Lifecycle Engineering – iRhythm Technologies, Inc.
We’re looking for a leader to support the lifecycle of complex medical device systems by managing projects that ensure quality, compliance, design, process improvement, and manufacturability while maintaining business continuity.
About This Role In this role, you will lead a team of highly skilled engineers and manage projects that drive product quality, compliance and supply continuity across a diverse portfolio. You will play a pivotal role within iRhythm’s Lifecycle Engineering (LCE) Center of Excellence, charting the company's capabilities and collaborating with cross‑functional teams.
What You Will Be Doing
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.
Ensure compliance with FDA QSR, ISO 13485, and ISO 14971, maintaining audit‑ready DHF/DMR and risk management files.
What We Want to See
BS degree in Engineering (Mechanical, Electrical, Biomedical) or related technical field; Master’s degree a plus.
8+ years of experience in medical device engineering, with 2+ years of experience managing an engineering team and/or 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, and authoring technical protocols and reports within a PLM database.
Ways to Stand Out
Knowledge of signal integrity analysis, power management, and thermal design for embedded systems a plus.
MS Office suite, experience with MS Project/Smartsheet a plus.
Certification in Lean/Six Sigma or PMP for structured problem‑solving and project leadership a plus.
Experience with cybersecurity for medical devices and wireless communication protocols (e.g., Bluetooth, Wi‑Fi) a plus.
Work Environment / Other Requirements
Location: Hybrid (Cypress, CA – Orange County).
Up to 10% travel to iSF (San Francisco facility).
Location Orange County, CA
Estimated Pay Range $135,000 – $175,000 per year
EEO Statement 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.
Accommodations iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures. If you need such an accommodation, you may contact us at taops@irhythmtech.com.
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, iRhythm’s vision is to deliver better data, better insights, and better health for all.
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About This Role In this role, you will lead a team of highly skilled engineers and manage projects that drive product quality, compliance and supply continuity across a diverse portfolio. You will play a pivotal role within iRhythm’s Lifecycle Engineering (LCE) Center of Excellence, charting the company's capabilities and collaborating with cross‑functional teams.
What You Will Be Doing
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.
Ensure compliance with FDA QSR, ISO 13485, and ISO 14971, maintaining audit‑ready DHF/DMR and risk management files.
What We Want to See
BS degree in Engineering (Mechanical, Electrical, Biomedical) or related technical field; Master’s degree a plus.
8+ years of experience in medical device engineering, with 2+ years of experience managing an engineering team and/or 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, and authoring technical protocols and reports within a PLM database.
Ways to Stand Out
Knowledge of signal integrity analysis, power management, and thermal design for embedded systems a plus.
MS Office suite, experience with MS Project/Smartsheet a plus.
Certification in Lean/Six Sigma or PMP for structured problem‑solving and project leadership a plus.
Experience with cybersecurity for medical devices and wireless communication protocols (e.g., Bluetooth, Wi‑Fi) a plus.
Work Environment / Other Requirements
Location: Hybrid (Cypress, CA – Orange County).
Up to 10% travel to iSF (San Francisco facility).
Location Orange County, CA
Estimated Pay Range $135,000 – $175,000 per year
EEO Statement 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.
Accommodations iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures. If you need such an accommodation, you may contact us at taops@irhythmtech.com.
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, iRhythm’s vision is to deliver better data, better insights, and better health for all.
#J-18808-Ljbffr