CTO/COO Co-Founder

Equity-Only Position (Full-Time Commitment) Company Stage: Pre-Seed / Seed MedTech startup

Compensation: 100% equity-based. Highly competitive salary after Seed round execution by Q1 2027. Significant founder-level equity. 4-year vesting. Location: Remote-first (U.S.-based required).

Who We Are We are an early-stage pediatric MedTech company developing a patented wearable platform for the non-invasive support of lower-limb alignment conditions in children. Our lead product, SmartAlign™, is built on more than a decade of university research and an initial clinical foundation.

We have established a three-member Medical Advisory Board and clinical testing relationships with two renowned universities in the U.S., with additional leading U.S. institutions in discussion. We are now raising our $3.5M Seed round and are looking for an exceptional technical co-founder who is ready to help build the product, technology platform, and company through its next stage.

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 and be the second or third most senior person in the company.

CTO Responsibilities (≈60% of time initially)

• 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 (≈40% of time initially, growing later)

• 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 simultaneously
• You have taken equity-only or very low-salary risk before and it paid off (or you’re ready to do it now because you believe in the mission)
• U.S. work authorization required (we cannot sponsor visas at this stage)

Why Join Now (Equity-Only)

• True co-founder status with founder-level equity and significant influence on company direction
• Opportunity to build something that will meaningfully improve (or save) millions of lives
• You will be the technical and operational backbone of the company for the next 3–5 years
• When we raise capital (targeting $3.5M seed in the next 3+ months), salary + benefits will be introduced at competitive market rates

This is a high-risk, extremely high-reward opportunity. If you need a salary today, this role is not for you. If you’re the kind of person who has been waiting for the right idea and the right team to go all-in, let’s talk. How to Apply

Send your LinkedIn, CV, and a short note (2–4 paragraphs max) explaining:

• The hardest MedTech product you’ve shipped and your exact role
• Why you’re ready to join an equity-only startup right now
• Anything else we absolutely need to know

Email: [email protected] (subject line: “CTO/COO Co-Founder Application – [Your Name]”)

We respond to every application that clearly meets the bar. No recruiters or agencies, please. We are an equal-opportunity employer and enthusiastically encourage people from underrepresented groups to apply.