Senior Systems Engineer

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

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.

Skills

Systems engineering

Regulatory compliance

Requirements definition

Mobile app data flow

IoT integration

Cross-functional leadership

Communication

Technical fluency

Education

Bachelor’s in Engineering or related field

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 SystemsEngineerIwithinthe 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 withFirmware engineers, Software Engineers, and cross-functional partners including Product/UX/Labeling,Human Factors,and Product Security, tofacilitatethe launch of both SaMD and non-medical device mobile applications.Thisroleprovidesan opportunity to engage with an experienced team, obtain comprehensive insight into integrated systems, and make significant contributions to the successful delivery of software projectsin both US and international markets.

Responsibilities:

• Facilitate stakeholder discussions to define and document system and subsystem requirementsas well as workflows, balancing technical, regulatory, and businessobjectives.

• 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 ondesign deliverables includingsoftware specifications, design documentation, and V&V strategies, including test protocols and reportsas well as regulatory submissions.

• Participate in risk management throughout product development and during field complaint investigations.

• Assistwith design transfer and software deployment activities.

• Remainup-to-datewith industry standards and regulatory requirements.

About You:

RequiredQualifications:

• Bachelor’sin Engineeringor related fieldrequired;NOTE:Candidates with aMaster’sor PhD may qualify with fewer years of relevant experience.

• Combined5+ years of experience in systems engineeringin a regulated industry (medical device preferred)

• Experience definingrequirements anddata flows for mobile applications (iOS/Android) connected to IoT hardware.

• Experience withstandardscompliance and risk management.

• Technicalfluency to effectively translate concepts and collaborate with softwareand firmwaredevelopers.

• Strong communicationand cross-functional leadership skills to align business, technical, and regulatory stakeholders.

PreferredQualifications:

• Experience with software based medical devices (SaMD orSiMD) and familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1)

• Familiarity withone or more IoT protocols -MQTT, CoAP, HTTP(S)

• Proficiencyin the use of requirements management tools, such as Jama,Polarion, or DOORs

• Knowledge of INCOSE/EARSbest practices and guidelines

• Knowledge ofSysML, UML, or other modeling techniques.

Location:

Remote - US

Estimated Pay Range

$115,000.00 - $149,000.00

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

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.