Director, Systems Engineering
iRhythm Technologies, Inc. · United States
- Hybrid
- Full-time
- $237,000 / year
- United States
Job highlights
- Lead Systems Engineering and Test for cardiac devices.
- Develop and mentor engineering teams.
- Drive adoption of engineering best practices.
- Ensure product safety, efficacy, and compliance.
- Collaborate with cross-functional departments.
About the role
Director, Systems 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
Role Summary
iRhythm is a leading designer and manufacturer of ambulatory cardiac monitoring wearable technologies, providing an end-to-end service that delivers a best-in-class wear experience, high reliability, and strong clinical value for patients and healthcare providers. At iRhythm, we start by solving for the patient and execute by thinking big and going fast, leading with integrity, collaborating to win, and always striving for better.
To continue advancing this mission, we are seeking a Director, Systems Engineering to join our organization, reporting to the Vice President of Product Development. This leader will oversee the Systems Engineering and Test functions within a regulated medical device product development environment.
The Director will provide strategic direction, technical leadership, and organizational capability-building across new product development and lifecycle management for connected cardiac monitoring technologies. This role will ensure teams apply disciplined systems engineering practices, including requirements management, architecture definition, interface control, risk management, verification strategy, design controls, and traceability. This leader will bring industry best practices into the organization, strengthen engineering rigor, and help ensure iRhythm’s products remain safe, effective, scalable, and compliant throughout their lifecycle.
Responsibilities
- Lead, develop, and mentor multidisciplinary Systems Engineering and Test teams supporting product development of cardiac diagnostic technologies from concept through commercial launch, as well as sustaining and lifecycle engineering activities.
- Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering, ensuring alignment with business priorities and portfolio roadmaps.
- Serve as an effective change agent by driving adoption of improved engineering processes, tools, and best practices while maintaining team engagement, compliance standards, and organizational momentum.
- Lead system-level requirements management, ensuring user needs are translated into clear, testable, traceable, risk-informed product, system, subsystem, software, hardware, firmware, and verification requirements.
- Communicate project status, risks, budget, resource needs, and execution priorities to executive leadership in a clear, concise, and actionable manner.
- Provide leadership support of external vendor partnerships, engineering evaluations, and verification testing of design changes as required.
- Partner cross-functionally with RA/QA, Product Management, Operations, Clinical, Manufacturing, and R&D functions to ensure design inputs and outputs meet regulatory, quality, customer, patient, user, and business needs.
- Sponsor a Systems Engineering community of practice, bringing industry best practices, training, standards awareness, and engagement with the broader systems engineering community (INCOSE, AAMI, MDIC, etc).
- Provide key planning inputs to ensure resource management, timelines, and budgets meet program and business needs.
- Provide oversight and targeted participation in QMS improvement initiatives, including DOP/SOP authoring and maintenance, to help ensure engineering processes are robust, efficient, compliant, and executable.
- Support regulatory inquiries, audits, inspections, and technical discussions, as required.
About You
- BS in Systems Engineering, Electrical Engineering, Biomedical Engineering or related engineering degree; MS/MBA a plus
- 15+ years in regulated medical device development (Class II/III Connected with deep experience in Systems Engineering across NPI and sustaining/lifecycle in regulated manufacturing environments.
- 8+ years of people leadership managing and developing multidisciplinary engineering teams (Systems Engineering; HW/FW/SW/mechanical integration)
- Expertise in systems engineering best practices: user needs → system/subsystem requirements, architecture, interface definition/control, requirements traceability, and configuration management.
- Experience developing medical device platforms that include hardware, firmware and tools/fixtures that interface with devices and/or data in a safe and secure way.
- Working knowledge of applicable regulatory standards and requirements, including FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 as applicable.
- Proven leadership of system-level risk management and design change execution in medical device development, including hazard analysis, dFMEA/pFMEA/uFMEA, impact assessments, V&V/regulatory strategy alignment, and design transfer support.
- Proven ownership of verification strategy and execution, including test planning, protocol/report oversight, coverage and traceability management, and ensuring robust evidence for product releases and design changes.
- Strong executive communication and cross-functional leadership, including vendor/partner governance, prioritization across multiple programs, and structured problem-solving (RCA/CAPA support)
- Experience supporting global regulatory submissions and responses, including FDA, EU MDR, and international submissions, with technical content and objective evidence.
Ways to Stand Out
- Prior experience supporting product development and systems engineering validation, or commercialization of cardiology, metabolic disease, diagnostic, or medical device technologies within regulated healthcare environments preferred.
- Working knowledge of AI-enabled tools and responsible-use practices within FDA-regulated medical device development environments
- Proven track record of delivery excellence; project management and organization skills
- Relevant certifications such as INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma
Location
On-site / hybrid / remote
Available for up to 25% domestic travel, primarily to San Francisco Bay Area or Southern California.
FLSA Status: Exempt
Location Details
Remote - US
Compensation
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range: $182,000.00 - $237,000.00
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.
Important Note on Recruitment Scams
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 taops@irhythmtech.com. 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
Key skills/competency
- Systems Engineering Leadership
- Medical Device Development
- Regulatory Compliance (FDA, ISO)
- Requirements Management
- Risk Management
- Verification and Validation Strategy
- Team Leadership and Mentorship
- Cross-functional Collaboration
- Product Lifecycle Management
- QMS Improvement
Skills & topics
- Director Systems Engineering
- Systems Engineering
- Medical Device
- Cardiac Monitoring
- Regulatory Affairs
- FDA
- ISO 13485
- Risk Management
- Verification
- Validation
- Product Development
- Leadership
- NPI
- Lifecycle Management
- Electrical Engineering
- Biomedical Engineering
- Hardware
- Firmware
- Software
- Test Engineering
- QMS
- INCOSE
- AAMI
- MDIC
- AI
- Remote
- Hybrid
- On-site
How to get hired
- Tailor your resume: Highlight 15+ years in regulated medical device development and 8+ years in leadership roles, emphasizing Systems Engineering expertise.
- Showcase regulatory knowledge: Detail experience with FDA QMSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601.
- Demonstrate leadership: Provide examples of managing multidisciplinary teams and driving process improvements.
- Prepare for interviews: Be ready to discuss strategic direction, technical leadership, and cross-functional collaboration.
- Research iRhythm: Understand their mission, values, and their role in cardiac health solutions.
Technical preparation
Behavioral questions
Frequently asked questions
- What are the key responsibilities for a Director of Systems Engineering at iRhythm Technologies?
- The Director of Systems Engineering at iRhythm Technologies will lead and mentor Systems Engineering and Test teams, oversee functional strategy and execution, drive adoption of best practices, manage system-level requirements, communicate project status to leadership, support vendor partnerships, and collaborate cross-functionally to ensure product safety, efficacy, and compliance throughout the lifecycle.
- What qualifications are essential for the Director of Systems Engineering role at iRhythm?
- Essential qualifications include a BS in a relevant engineering field (MS/MBA a plus), 15+ years in regulated medical device development with deep Systems Engineering experience, and 8+ years of people leadership managing multidisciplinary engineering teams. Expertise in systems engineering best practices, medical device platforms, and relevant regulatory standards (FDA, ISO, IEC) is crucial.
- How does iRhythm Technologies ensure product safety and compliance in their medical devices?
- iRhythm Technologies ensures product safety and compliance through disciplined systems engineering practices, including meticulous requirements management, architecture definition, risk management, verification strategy, design controls, and traceability. They adhere to strict regulatory standards such as FDA QMSR, ISO 13485, and relevant IEC standards, with a focus on continuous QMS improvement.
- What is the work arrangement and travel expectation for this Director of Systems Engineering position?
- This position is offered as on-site, hybrid, or remote within the US. There is an expectation of up to 25% domestic travel, primarily to the San Francisco Bay Area or Southern California.
- What is the estimated salary range for the Director of Systems Engineering at iRhythm Technologies?
- The estimated pay range for the Director of Systems Engineering role at iRhythm Technologies is $182,000.00 to $237,000.00 annually, with actual compensation varying based on factors such as knowledge, skills, experience, and work location.
- How can candidates differentiate themselves for the Director of Systems Engineering role at iRhythm?
- Candidates can stand out by having prior experience supporting product development and systems engineering validation or commercialization of cardiology or diagnostic medical devices. Knowledge of AI-enabled tools in FDA-regulated environments, a proven track record of delivery excellence, and relevant certifications like INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma are also advantageous.