Co-founder CTO/COO

WE'RE HIRING! COO/CTO - CO-FOUNDER MED TECH FOUNDER EQUITY! PLS REACH TO ME DIRECTLY FOR CONSIDERATION! Highly competitive salary after Seed round execution by mid 2026. Significant founder-level equity. Location: Remote-first (U.S.-based required). Who We Are We are an early-stage MedTech company developing a breakthrough technology in pediatric orthopedics. We have a working prototype, initial pre-clinical data, strong IP (patented), and in process with LOIs from key opinion leaders and potential strategic partners. We are now raising our seed round and need an exceptional technical + operational co-founder. The Role This is a true co-founder role combining CTO and COO responsibilities. You will wear both hats until we can hire dedicated leaders underneath you (likely post-Series A). You will report directly to the CEO. CTO Responsibilities Own the entire technical roadmap and product architecture Lead all engineering (hardware, firmware, software, AI/ML, cloud, mobile app, regulatory-critical systems) Build and manage the engineering team (initially hiring contractors/freelancers, then full-time hires) Oversee design controls, risk management (ISO 14971), cybersecurity (IEC 62304, FDA guidance), and software as a medical device (SaMD) or SiMD requirements Drive technical due diligence with investors and strategic partners Manage external development partners (contract manufacturers, design firms, CROs) Ensure the product is designed for FDA clearance/approval pathway (510(k) or De Novo/PMA) from day one COO Responsibilities Build and scale all operational systems (supply chain, quality, regulatory affairs) Own the Quality Management System (QMS) implementation (21 CFR Part 820, ISO 13485) Lead regulatory strategy and submissions (FDA, EU MDR, etc.) in collaboration with consultants Manage budget, burn rate, and cap table (with CEO) Recruit and onboard the first hires Establish manufacturing strategy and early supply chain relationships Oversee grant applications (NIH, NSF, Breakthrough Device Designation, etc.) Who You Are Prior STARTUP experience - and attitude - HIGHLY PREFERRED. 8–15+ years of deep MedTech/FDA-regulated experience (medical device, digital health, diagnostics, or combination products) Proven track record taking at least one Class II or Class III device from concept through FDA clearance/approval and commercial launch Hands-on engineering leader who has personally built hardware + software medical products (electrical, mechanical, firmware, cloud, AI/ML experience a big plus) Experience implementing QMS (ISO 13485 / 21 CFR 820) from scratch Comfortable operating with extreme ambiguity and resource constraints Willing to roll up sleeves and code, solder, write SOPs, negotiate with manufacturers, and recruit U.S. work authorization required Why Join Now (Equity-Only) True co-founder status with founder-level equity and significant influence on company direction