Chief Technology Officer (CTO) — MedTech Wearables & FDA Device Approval
Location: Scottsdale, AZ / Remote (with travel to HQ)
Company: Early-Stage MedTech Startup
Compensation: Competitive salary + equity stake + milestone bonuses
Our start-up is pioneering the future of med tech diagnostic AI and wearable biosensing technology to revolutionize medical adherence and early disease detection. Our mission is to develop a FDA-cleared Class II medical device that seamlessly integrates AI-driven analytics with breakthrough biosensors for continuous, non-invasive health monitoring.
Role Overview
We’re seeking a dynamic, hands-on CTO with deep expertise in medical device development and FDA regulatory approval processes to join as a cofounder or early executive. This role will be pivotal in guiding product development, regulatory strategy, and building a high-performing technical team.
Key Responsibilities
• Lead end-to-end design, prototyping, and testing of our app, wearable biosensing medical device hardware and software.
• Develop and execute a clear FDA 510(k) or De Novo regulatory submission strategy and manage interactions with regulatory bodies.
• Oversee clinical trial design coordination and validation protocols.
• Build and scale an engineering team, including firmware, embedded systems, cloud infrastructure, and AI integration.
• Collaborate closely with founders and investors to align product milestones with fundraising and commercialization plans.
• Establish strong partnerships with contract manufacturers, CROs, and labs for rapid product iteration.
• Implement quality systems in compliance with ISO 13485 and 21 CFR Part 820 standards.
Must-Have Qualifications
• 5+ years in medical device development, ideally wearables or biosensors, with proven success in launching FDA Class II or III devices.
• Hands-on experience managing or personally driving FDA 510(k) or De Novo submissions, with clear regulatory approval track record.
• Deep understanding of hardware-software integration, embedded firmware, signal processing, and cloud-based medical analytics.
• Familiarity with clinical validation protocols, including IRB processes and working with CROs.
• Prior leadership role in a startup or early-stage medtech company (founder or senior exec).
• Knowledge of applicable quality standards and compliance (ISO 13485, ISO 14971, IEC 62304).
• Excellent communication skills to present complex regulatory and technical issues to investors and partners.
Nice-to-Haves
• MBA, MS, or PhD in Biomedical Engineering, Electrical Engineering, or related field.
• Experience with AI/ML integration in medical devices.
• Existing network of medtech industry contacts, including FDA, clinical investigators, and manufacturing partners.
• Prior fundraising or investor relations experience.
Why Join us?
• Become a founding leader in a high-impact medtech startup focused on longevity and adherence.
• Work with a visionary founder backed by strong early investor interest.
• Equity participation with opportunity for meaningful upside.
• Influence product direction and corporate strategy from day one.
• Access to an expanding network of medtech advisors and accelerators
