Sr. Systems Engineer II - ECG Monitoring Applications

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 detail ed 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 doc ument s, test plans, and reports.
• Collaborate with cross- functional teams to establish workflows and ensure seamless system integration.
• Conduct compliance gap as sessments, 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:
• Y ou ...
• A re 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 initiati ve in he lping others
• Have effective presentation and interpersonal skills
• Required Qualifications :
• Bachelor's in E ngineering 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).
• Exp erience with software development using one or more of Python (or equivalent scripting language), Java, C #, or C/C++.
• Experience d evelop ing technical product/software requirements , system architecture and trace matrices .
• Experience supporting risk management activities .

Requirements

• E xperience 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)
• P roficiency in the use of requirements management tools, such as Jama, Polarion , or DOORs
• Knowledge of INCOSE /EARS best practices and guidelines; ASEP/CSEP certi fication 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
• iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. I

Benefits

Additional Information

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 c ollaborating with specialists in Data Science/Machine Learning, Software Engineering, Mobile Technologies, Product/UX, Product Security, and Clinical, you wi ll 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.

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