Sr. 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 (with a Bachelors), with at least 2 years of experience working on developing software-based medical devices (SaMD/SiMD).
- Required Skills
- PythonRisk 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 the basics of statistics, including calculation of algorithm performance metrics.
- 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.
Responsibilities
- Lead stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals.
- 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).
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