Sr. Systems Engineer II - Platform Services
New
I
iRhythm Technologies, Inc.Digital healthcare
Remote - USFull-TimeSenior
Salary127,000 - 165,000 USD per year
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Job Details
- Experience
- 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). Master’s or PhD may qualify with fewer years.
- Required Skills
- PythonJavaC#C++Risk Management
Requirements
- Bachelor’s degree in Engineering or a related field.
- 8+ years of systems engineering experience (with a Bachelor’s degree).
- 2+ years of experience working on developing software-based medical devices (SaMD/SiMD).
- Understanding of statistics, specifically the calculation of algorithm performance metrics (sensitivity, specificity).
- Experience with software development using Python, Java, C#, or C/C++.
- Experience developing technical product/software requirements, system architecture, and trace matrices.
- Experience supporting risk management activities.
- Proficiency in requirements management tools (e.g., Jama, Polarion, or DOORs) preferred.
- Knowledge of MBSE, SysML, or UML preferred.
- Familiarity with medical device regulations (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1) preferred.
- Experience using Splunk for data analysis preferred.
Responsibilities
- Lead stakeholder discussions to define and document system and subsystem requirements.
- Maintain detailed system architecture documentation and models (e.g., SysML).
- Support post-market monitoring of algorithm performance using Python and investigate field complaints.
- Manage end-to-end product trace matrices illustrating design input/output relationships.
- Review technical deliverables including 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 and assist with regulatory submissions (IEC 62304, ISO 14971).
- Support cybersecurity initiatives and integrate security best practices into designs.
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