Sr. Systems Engineer I
New
Remote - USFull-TimeSenior
Salary115,000 - 149,000 USD per year
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Job Details
- Experience
- Combined 5+ years of experience in systems engineering (with a Bachelors)
- Required Skills
- IoTRisk Management
Requirements
- Bachelor’s in Engineering or related field.
- 5+ years of experience in systems engineering (for candidates with a Bachelor's degree), ideally in a regulated industry such as medical device, automotive, or aerospace.
- Experience defining requirements and data flows for mobile applications (iOS/Android) connected to IoT hardware.
- Experience with standards compliance and risk management.
- Technical fluency to effectively collaborate with software and firmware developers.
- Strong communication and cross-functional leadership skills.
- Familiarity with software-based medical devices (SaMD or SiMD) is preferred.
- Familiarity with medical device regulations and standards like FDA, ISO 13485, ISO 14971, IEC 62304, or IEC 60601-1 is preferred.
- Familiarity with IoT protocols such as MQTT, CoAP, or HTTP(S) is preferred.
- Proficiency in requirements management tools like Jama, Polarion, or DOORs is preferred.
- Knowledge of INCOSE/EARS best practices and modeling techniques like SysML or UML is preferred.
Responsibilities
- Facilitate stakeholder discussions to define and document system and subsystem requirements and workflows.
- Oversee the end-to-end data flow from the medical device, through mobile connectivity (BLE, Cellular, Wi-Fi), and into the cloud infrastructure.
- Maintain and update system architecture documents and models to reflect current designs.
- Manage trace matrices linking design inputs to outputs at system and enterprise levels.
- Review software specifications, design documentation, and V&V strategies, including test protocols and reports.
- Participate in risk management throughout product development and during field complaint investigations.
- Assist with design transfer and software deployment activities.
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