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Sr. Systems Engineer I at iRhythm. Location Information: . 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:. About this Role:. As a Senior Systems. Engineer. I. within. the Research & Systems Engineering team, you will play a key role in the development and enhancement of Mobile Applications supporting the Zio service. This position requires close collaboration with. Firmware engineers, Software Engineers. , and cross-functional partners including Product/UX. /Labeling,. Human Factors,. and Product Security, to. facilitate. the launch of both SaMD and non-medical device mobile applications.. This. role. provides. an opportunity to engage with an experienced team, obtain comprehensive insight into integrated systems, and make significant contributions to the successful delivery of software projects. in both US and international markets. .. Responsibilities. :. Facilitate stakeholder discussions to define and document system and subsystem requirements. as well as workflows. , balancing technical, regulatory, and business. objectives. .. Oversee the end-to-end data flow from the medical device, through mobile connectivity (e.g., BLE,. Cellular,. Wi-Fi), and into the cloud infrastructure.. Maintain and update system architecture documents and models to accurately reflect current designs.. Contribute to the management of trace matrices linking design inputs to outputs at both system and enterprise levels.. Review and provide input on. design deliverables like -. software specifications, design documentation, and V&V strategies, including test protocols and reports. as well as regulatory submissions.. Participate in risk management throughout product development and during field complaint investigations.. Assist. with design transfer and software deployment activities.. Remain. up-to-date. with industry standards and regulatory requirements.. About You:. Required. Qualifications. :. Bachelor’s. in Engineering. or related field. required. ;. Combined. 5+ years of experience in systems engineering. (with a Bachelors). ,. ideally. in a regulated. industry. (. e.g.. medical device, automotive, aerospace, etc.). . . NOTE:. Candidates with a. Master’s. or PhD may qualify with fewer years of relevant experience.. Experience defining. requirements and. data flows for mobile applications (iOS/Android) connected to IoT hardware.. Experience with. standards. compliance and risk management.. Technical. fluency to effectively translate concepts and collaborate with software. and firmware. developers. .. Strong communication. and cross-functional leadership skills to align business, technical, and regulatory stakeholders.. Preferred. Qualifications. :. Experience with software based medical devices (SaMD or. SiMD. ) and f. amiliarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1). Familiarity with. one or more IoT protocols -. MQTT, CoAP, HTTP(S. ). Proficiency. in the use of requirements management tools, such as Jama,. Polarion. , or DOORs. Knowledge of INCOSE. /EARS. best practices and guidelines. Knowledge of. SysML. , UML, or other modeling techniques.. Location:. Remote - US. Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.. Estimated Pay Range. $115,000.00 - $149,000.00. As 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