Note: The job is a remote job and is open to candidates in USA. iRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions for cardiac health. The Senior Systems Engineer II will develop and support software services for arrhythmia detection while collaborating with various specialists to tackle engineering and data science challenges.
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
Skills
- 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
- 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
Company Overview
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