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iRhythm Technologies, Inc.

Sr. Systems Engineer II - Platform Services

RemoteUnited States only
Published
Role
Engineering Management
Experience
Senior
$138k–$180k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

As a Senior Systems Engineer II - Platform Services in the Research & Systems Engineering team, you will be instrumental in developing and supporting software services enabling during-wear arrhythmia detection and reporting.

Required skills

Python/Java/C#/C/C++SysMLUMLSplunkJama/Polarion/DOORS

Required languages

English unknown

What you'll do

  • 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.

What they require

  • Bachelor's degree in Engineering or related field
  • Combined 8+ years of systems engineering experience (with a Bachelor's), with at least 2 years of experience working on developing software-based medical devices (SaMD/SiMD)
  • 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)
  • Knowledge of INCOSE/EARS best practices and guidelines; ASEP/CSEP certification considered advantageous
  • Knowledge of Model-Based Systems Engineering (MBSE)
  • Experience using Splunk for data analysis and monitoring

Benefits

  • Career-defining, life-changing opportunity
  • Inclusive workforce
  • Equal Opportunity Employer
  • Reasonable accommodations for qualified individuals with disabilities

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.

HealthcareEnterprise
$138k–$180k/yr