Sr. Systems Engineer I (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Sr. Systems Engineer I (IoT/Medtech): Developing and enhancing mobile applications for the Zio cardiac service with an accent on system requirements, data flow, and regulatory compliance. Focus on integrating IoT hardware with cloud infrastructure, managing risk, and ensuring alignment between technical and business objectives.
Location: Remote (Must be based in the US)
Salary: $115,000 - $149,000
Company
is a leading digital healthcare company creating wearable biosensor and cloud-based analytics solutions for cardiac disease detection and prevention.
What you will do
- Define and document system and subsystem requirements and workflows, balancing technical, regulatory, and business goals.
- Oversee end-to-end data flow from medical devices through mobile connectivity (BLE, Cellular, Wi-Fi) to cloud infrastructure.
- Maintain and update system architecture documents and models.
- 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 regulatory submissions.
- Participate in risk management and assist with design transfer and software deployment activities.
Requirements
- Bachelor’s degree in Engineering or a related field.
- 5+ years of systems engineering experience, ideally in regulated industries such as medical devices, automotive, or aerospace.
- Experience defining requirements and data flows for iOS/Android mobile applications connected to IoT hardware.
- Proven experience with standards compliance and risk management.
- Technical fluency to collaborate effectively with software and firmware developers.
- Strong communication and cross-functional leadership skills to align stakeholders.
Nice to have
- Experience with software-based medical devices (SaMD or SiMD) and familiarity with FDA, ISO 13485, ISO 14971, IEC 62304, or IEC 60601-1.
- Familiarity with IoT protocols such as MQTT, CoAP, or HTTP(S).
- Proficiency in requirements management tools like Jama, Polarion, or DOORs.
- Knowledge of INCOSE/EARS best practices and SysML/UML modeling techniques.
Culture & Benefits
- Mission-driven environment focused on improving global cardiac health.
- Opportunities for rapid career growth and skill advancement within a growing organization.
- Inclusive workplace culture celebrating diverse backgrounds and perspectives.
- Flexible remote work arrangement within the United States.
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