Irhythmtech
Director, Systems Engineering
Remote - US · Director
Sponsorship not specified$182k-$237kDetected 30 days ago
AlgorithmsData AnalysisProject ManagementProcess ImprovementSystems EngineeringElectrical EngineeringPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationProblem Solving
About the role
- 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.
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.
- 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.
- 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.
- Every day, we collaborate, create, and constantly reimagine what's possible.
Requirements
- Provide leadership support of external vendor partnerships, engineering evaluations, and verification testing of design changes as required.
- Support regulatory inquiries, audits, inspections, and technical discussions, as required.
Nice to have
- BS in Systems Engineering, Electrical Engineering, Biomedical Engineering or related engineering degree
- HW/FW/SW/mechanical integration)
- 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.
- Experience supporting global regulatory submissions and responses, including FDA, EU MDR, and international submissions, with technical content and objective evidence.
- Proven track record of delivery excellence
- project management and organization skills
- Relevant certifications such as INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma
Compensation
- Estimated Pay Range
Benefits
- Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
- iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.
- Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.
Company info
- As a part of our core values, we ensure an inclusive workforce.
Equal opportunity
- Equal Opportunity Employer.
- If you need such an accommodation, you may contact us at taops@irhythmtech.com
Visa & Work Authorization
- Sponsor a Systems Engineering community of practice, bringing industry best practices, training, standards awareness, and engagement with the broader systems engineering community (INCOSE
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This listing is sourced directly from Irhythmtech's careers page and normalized into a canonical job model.