Sr. Systems Engineer II - Platform Services
New
Remote - USFull-TimeSenior
Salary127,000 - 165,000 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
- Required Skills
- PythonJavaC#C++Risk Management
Requirements
- Bachelor’s in Engineering or related field.
- 8+ years of systems engineering experience (with a Bachelors).
- At least 2 years of experience working on developing software-based medical devices (SaMD/SiMD).
- Understanding of statistics, including calculation of algorithm performance metrics.
- Software development experience using Python, 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 (preferred).
- Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1) (preferred).
- Proficiency in requirements management tools (e.g., Jama, Polarion, or DOORs) (preferred).
- Knowledge of SysML, UML, or Model-Based Systems Engineering (MBSE) (preferred).
- Experience using Splunk for data analysis and monitoring (preferred).
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).
- Support cybersecurity initiatives and integrate security best practices into system and subsystem designs.
- Contribute to design transfer and software deployment or launch activities.
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