Senior Systems Engineer II - ECG Monitoring Applications

New
Remote - USFull-TimeSenior
Salary138,000 - 180,000 USD per year
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Job Details

Experience
8+ years of systems engineering experience
Required Skills
PythonJavaC#C++Risk Management

Requirements

  • Bachelor’s in Engineering or related field
  • 8+ years of systems engineering experience (with a Bachelor’s)
  • At least 2 years of experience working on developing software-based medical devices (SaMD/SiMD)
  • Understanding of statistics and calculation of algorithm performance metrics
  • Experience with Python, Java, C#, or C/C++
  • Experience developing technical product/software requirements, system architecture, and trace matrices
  • Experience supporting risk management activities

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
  • Manage end-to-end product trace matrices
  • 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 and assist with regulatory submissions
  • Support cybersecurity initiatives and integrate security best practices
  • Contribute to design transfer and software deployment or launch activities
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138,000 - 180,000 USD per year
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