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: Hybrid (Cypress, CA – Orange County)
- Up to 10% travel to iSF (San Francisco facility)
Location:
Orange CountyActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$135,000.00 - $175,000.00As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. 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.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]
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.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
