Senior Systems Engineer I – SaMD Mobile Apps (Remote)

iRhythm Technologies, Inc.; United States; Remote; USD 115,000 - 149,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Senior Systems Engineer I for its Research & Systems Engineering team to develop and enhance Mobile Applications supporting the Zio service.

You will collaborate with Firmware, Software, and cross-functional partners to enable SaMD and non-medical apps for US and international markets. Responsibilities include defining requirements, managing data flows from device to cloud, maintaining architecture docs, and supporting risk management and regulatory

Qualifications

• Bachelor's degree in engineering or related field required.
• Combined 5+ years of systems engineering experience in regulated industry.
• Experience defining requirements and data flows for mobile apps (iOS/Android) connected to IoT hardware.
• Experience with standards compliance and risk management.
• Strong communication and cross-functional leadership.

Responsibilities

• Facilitate stakeholder discussions to define and document system and subsystem requirements and workflows.
• Oversee end-to-end data flow from medical device to cloud infrastructure.
• Maintain and update system architecture documents and models.
• Manage trace matrices linking design inputs to outputs at system and enterprise levels.
• Review design deliverables including software specs, design docs, and V&V strategies, including test protocols and regulatory submissions.
• Participate in risk management during product development and field investigations.
• Assist with design transfer and software deployment activities.
• Stay up-to-date with industry standards and regulatory requirements.

Skills

System engineering

Regulated industry

Mobile app requirements

Regulatory risk

Cross-functional leadership

Communication

Education

Bachelor's in Engineering

Tools

Jama

Polarion

DOORs

Job description

iRhythm Technologies, Inc. is seeking a Senior Systems Engineer I for its Research & Systems Engineering team to develop and enhance Mobile Applications supporting the Zio service.

You will collaborate with Firmware, Software, and cross-functional partners to enable SaMD and non-medical apps for US and international markets. Responsibilities include defining requirements, managing data flows from device to cloud, maintaining architecture docs, and supporting risk management and regulatory