FDE Systems Engineer - MedTech

Job Description

### **FDE Systems Engineer - MedTech**

### **About SynthBee Inc.**

At SynthBee we're building Collaborative Intelligence™ maximising the potential of people and computers working together. CI™ will help humans solve the most important scientific, engineering, design, and creative challenges of our time. And create joy in the process.
We are looking for a Systems Engineer with 7 years of experience in the medical device space to serve as the architectural bridge between clinical user needs and technical implementation. This person will translate Voice of Customer data into actionable software and hardware requirements for one of SynthBee's most advanced client  
implementations---helping bring next-generation medical device platforms to life.
What will you be doing?

• Translating customer discovery calls and requirements into actionable design inputs on the software and systems side for medical devices  
• Building out functionality for 2D diagramming, 3D modeling, and simulation analysis in partnership with CAE/FEA engineers  
• Serving as the technical liaison between clinical stakeholders and cross-functional engineering teams (firmware, embedded systems, application software)  
• Operating in the "middle ground" of the product development lifecycle---gathering requirements, translating them into real engineering inputs, and shepherding through to client delivery  
• Managing design controls, risk analyses (FMEA), and compliance with international medical device standards (ISO 13485, IEC 62304, ISO 14971)

**Key Requirements**
• 7 years of systems engineering experience within medical devices, surgical robotics, or advanced digital health (invasive/surgical tools preferred over battery packs or HMS)  
• Proven ability to translate customer/clinical conversations into actionable technical requirements for software and hardware teams  
• Deep understanding of the SDLC for medical products---embedded software, monitoring/tracking software, cloud systems, and hardware interfaces  
• Must be a US citizen or green card holder willing to relocate to Florida  
• Solid tenure at recent roles---no excessive job hopping