The Team

The successful candidate will join the Systems, Electrical, and Embedded SW (SEE) team responsible for the development and testing required to produce a commercial-ready Brain-Computer Interface (BCI) system. This system is comprised of active implantable components and non-implantable elements that facilitate signal communication to everyday devices.

This individual will contribute as part of a cross functional team driving a BCI system through development, regulatory approval, and commercialization. The ideal candidate will have some experience working in cross-functional teams and in a regulated industry, such as active implanted medical devices.

This team member will work collaboratively with internal and external resources to define system design, lead system testing, support clinical studies, and support regulatory review. This team member will be central to all systems engineering activities across all Synchron systems.

Position Responsibilities 

• High level: lead the system design, system test, and system documentation for Synchron BCI systems. Engage in the support of clinical studies and support regulatory review. 
• Engage with the current Systems, Electrical, and Embedded SW (SEE) team and proactively propose solutions to technical problems and optimization needs across the system.
• Effectively communicate system design, test strategy, plans, and status to internal stakeholders. 
• Manage requirements and requirements tracing at the system level. 
• Engage with the risk management team to ensure design and test incorporates risk management inputs. 
• Lead System-level decisions while engaging a cross-functional team. 
• Engage with users and medical professionals to ensure system design and test meet the needs of the users.
• Lead issue resolution and tracking across system elements.
• Understand and support existing Synchron BCI systems through clinical trial support. 
• Help establish best-in-class systems design processes and tools for Synchron and the SEE team. 

Minimal Qualifications

• Bachelor’s degree or equivalent practical experience in electrical/biomedical engineering or related technical field.
• 7 years of system engineering or similar experience. 
• Experience with medical device development or similar regulated industry experience 
• Experience working in cross-functional teams.

Preferred Qualifications

• Advanced degree or equivalent experience in electrical/biomedical engineering or related technical field 
• Experience with active implanted medical devices. 
• 10 years of system engineering or similar experience.
• Experience verifying and validating system requirements and user needs.