Remote Senior Systems Engineer — IoT MedTech

iRhythm

United States

Remote

USD 115,000 - 149,000

Full time

13 days ago

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Job summary

iRhythm Technologies, Inc. is seeking a Senior Systems Engineer I to join the Research & Systems Engineering team.

You will help develop mobile applications supporting the Zio service, collaborating with firmware, software, and cross-functional partners to enable SaMD and non-medical apps for US and international markets. You will engage with an experienced team, work on end-to-end data flows from devices to cloud, and contribute to design, risk management, and regulatory submissions while

Qualifications

Bachelor’s in Engineering or related field required; Master’s or PhD may qualify with fewer years of relevant experience.
Combined 5+ years of experience in systems engineering in a regulated industry (medical device preferred).
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 translate concepts and collaborate with software and firmware developers.
Strong communication and cross-functional leadership to align stakeholders.

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 reflect current designs.
Contribute to the management of trace matrices linking design inputs to outputs at system and enterprise levels.
Review and provide input on design deliverables including 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.