Manager, Lifecycle Engineering

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:

In this role, you will support the lifecycle of complex medical device systems by leading a team of highly skilled engineers and managing projects ensuring quality, compliance, design, process improvement, and manufacturability while maintaining business continuity. 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.

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