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