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iRhythm

Sr. Systems Engineer II - ECG Monitoring Applications

iRhythm

84d ago

0$138k - $180kDevUnited Stateshimalayas
Systems-EngineeringMedical-Device-EngineeringECG-MonitoringHealthcare-Technology-EngineeringSoftware-Systems-EngineeringSenior-Healthcare-Systems-EngineerSenior-Systems-EngineerSenior-Clinical-Solutions-EngineerSenior-Systems-EngineeringSenior-Product-Engineering-Manager---Clinical-SystemsSenior

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 careerAbout This Role:About this Role:As a Senior Systems EngineerII - ECG Monitoring Applicationsin the Research & Systems Engineering team, you will be instrumental in developing and supportingsoftware services enablingduring-weararrhythmia detectionand reporting.By collaborating with specialists in Data Science/Machine Learning, Software Engineering, Mobile Technologies,Product/UX,Product Security,and Clinical,youwill tackle a wide range of software engineering and data science challenges toaddress unmetclinical 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.KeyResponsibilities:Lead stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals; perform trade-off analyses and present recommendations toleadership foralignment.Maintain detailed system architecture documentation and models (e.g.,SysML), ensuringaccuratesystem 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 relationshipsReview and provide technical input to design deliverables likesoftware specifications, design documents, test plans, and reports.Collaborate with cross-functionalteams 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…Arequality-minded withtheability todive into technical detailswhilestillhaving the big picture in mindEnjoy investigative and troubleshooting processes using your excellent analytical and problem-solving skillsAreself-motivated and demonstrate initiative in helping othersHave effective presentation and interpersonal skillsRequiredQualifications:Bachelor’s inEngineeringor relatedfield;Combined8+yearsofsystems engineering experience(with a Bachelors),withat least 2 years ofexperienceworking on developingsoftware-based medical devices (SaMD/SiMD).Note: Candidates with aMaster’sor PhD may qualify with fewer years of relevant experience.Understanding the basics of statistics - including calculation of algorithmperformance metrics (e.g., sensitivity, specificity).Experiencewith software development usingone or more ofPython (or equivalent scripting language), Java, C#,orC/C++.Experience developing technical product/software requirements, systemarchitectureand trace matrices.Experiencesupportingrisk managementactivities.PreferredQualifications:Experiencesupportingprojects employing Scrum and Agile methodologiesFamiliarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1)Proficiencyin the use of requirements management tools, such as Jama,Polarion, or DOORsKnowledge of INCOSE/EARSbest practices and guidelines; ASEP/CSEP certificationconsideredadvantageousKnowledge ofSysML, UML,orbroadly,Model-Based Systems Engineering (MBSE)ExperienceusingSplunk for data analysis and monitoringLocation:Remote - USActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.Estimated Pay Range$138,000.00 - $180,000.00As 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 taops@irhythmtech.comAbout iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that