Duties & Responsibilities
- Lead, scale, and mentor a multi-disciplinary R&D department spanning hardware, firmware, software, and production engineering
- Drive high-level system architecture across the full technology stack — embedded systems, mobile applications, and cloud environments
- Take ownership of the full product lifecycle from R&D scoping and prototyping through to validation, production engineering, and commercial launch
- Establish frameworks for design reviews, architecture documentation, and quality control; manage R&D budgets, resource allocation, and timelines
- Ensure all hardware and software designs adhere to medical standards (ISO 13485, IEC 60601, IEC 62304) and guide the team through FDA and CE submission processes
- Collaborate with product management, clinical teams, and executive leadership to align technology with commercial goals
Experience & Qualifications- Bachelor's degree in Electronic, Electrical, Biomedical, or Computer Engineering (Master's advantageous)
- 10+ years of engineering experience with a proven track record of taking complex products from concept to commercial release
- 3+ years in a senior management or director-level role leading multi-disciplinary technical teams
- Experience in a regulated industry (medical devices, aerospace, or automotive)
- Architectural proficiency across: C++ (embedded), JavaScript/Node.js, Python, Rust, C#, Bash
- Demonstrated experience with AWS cloud environments and hardware design in a manufacturing/production setting
- Advantageous: Embedded Linux (Yocto Project), React Native, FDA software/hardware submission experience