Sr. Systems Engineer II - ECG Monitoring Applications

Remote Full-time
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:
About this Role:

As a Senior Systems Engineer II - ECG Monitoring Applications in the Research & Systems Engineering team, you will be instrumental in developing and supporting software services enabling during-wear arrhythmia detection and reporting. By collaborating with specialists in Data Science/Machine Learning, Software Engineering, Mobile Technologies, Product/UX, Product Security, and Clinical, you will tackle a wide range of software engineering and data science challenges to address unmet clinical needs. This role gives you the chance to work alongside a skilled team, gain an in-depth understanding of our integrated systems, and contribute to the successful completion of software projects throughout their development cycle.

Key Responsibilities:

Lead stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals; perform trade-off analyses and present recommendations to leadership for alignment.

Maintain detailed system architecture documentation and models (e.g., SysML), ensuring accurate system representation.

Support post-market monitoring of algorithm performance, including scripting (Python), and contribute to risk management and field complaint investigations.

Manage end-to-end product trace matrices, illustrating design input/output relationships

Review and provide technical input to design deliverables like software specifications, design documents, test plans, and reports.

Collaborate with cross-functional teams to establish workflows and ensure seamless system integration.

Conduct compliance gap assessments, assist with regulatory submissions, and stay current with relevant standards (IEC 62304, ISO 14971, cybersecurity frameworks).

Support cybersecurity initiatives and integrate security best practices into system and subsystem designs.

Contribute to design transfer and software deployment or launch activities.



About You:

You…

Are quality-minded with the ability to dive into technical details while still having the big picture in mind

Enjoy investigative and troubleshooting processes using your excellent analytical and problem-solving skills

Are self-motivated and demonstrate initiative in helping others

Have effective presentation and interpersonal skills



Required Qualifications:

Bachelor’s in Engineering or related field;

Combined 8+ years of systems engineering experience (with a Bachelors), with at least 2 years of experience working on developing software-based medical devices (SaMD/SiMD). Note: Candidates with a Master’s or PhD may qualify with fewer years of relevant experience.

Understanding the basics of statistics - including calculation of algorithm performance metrics (e.g., sensitivity, specificity).

Experience with software development using one or more of Python (or equivalent scripting language), Java, C#, or C/C++.

Experience developing technical product/software requirements, system architecture and trace matrices.

Experience supporting risk management activities.



Preferred Qualifications:

Experience supporting projects employing Scrum and Agile methodologies

Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1)

Proficiency in the use of requirements management tools, such as Jama, Polarion, or DOORs

Knowledge of INCOSE/EARS best practices and guidelines; ASEP/CSEP certification considered advantageous

Knowledge of SysML, UML, or broadly, Model-Based Systems Engineering (MBSE)

Experience using Splunk for data analysis and monitoring

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

Estimated Pay Range
$138,000.00 - $180,000.00
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 [email protected]

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.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121

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