Senior Systems Engineer

🕒 May 22

🇺🇸 United States – Remote

💵 $115k - $149k / year

⏰ Full Time

🟠 Senior

⚙️ Systems Engineer

👻 Ghost score 33%

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Logo of iRhythm Technologies, Inc.

iRhythm Technologies, Inc.

1001 - 5000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• Facilitate stakeholder discussions to define and document system and subsystem requirements and workflows • Balance technical, regulatory, and business objectives • Oversee end-to-end data flow from the medical device through BLE, cellular, Wi-Fi, and cloud infrastructure • Maintain and update system architecture documents and models • Contribute to trace matrices linking design inputs to outputs at system and enterprise levels • Review software specifications, design documentation, V&V strategies, test protocols, test reports, and regulatory submissions • Participate in risk management throughout product development and field complaint investigations • Assist with design transfer and software deployment activities • Remain up to date with industry standards and regulatory requirements • Collaborate with firmware engineers, software engineers, Product/UX/Labeling, Human Factors, and Product Security teams to support mobile application launches

🎯 Requirements

• Bachelor’s in Engineering or related field required • 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 skills • Preferred: Experience with software-based medical devices (SaMD or SiMD) and familiarity with medical device regulations and standards, including FDA, ISO 13485, ISO 14971, IEC 62304, and IEC 60601-1 • Preferred: Familiarity with MQTT, CoAP, or HTTP(S) • Preferred: Proficiency with requirements management tools such as Jama, Polarion, or DOORS • Preferred: Knowledge of INCOSE/EARS best practices and guidelines • Preferred: Knowledge of SysML, UML, or other modeling techniques

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