Sr. Systems Engineer I

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

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

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 familiarity 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 [e-mail]

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.