Lead Medical Device Development
We are seeking a highly motivated and experienced Chief Technical Officer (CTO) to lead our technical strategy and execution in the development of a next-generation electronic software medical device.
The ideal candidate will bring a strong technical background in medical device R&D, proven start-up experience, and deep knowledge of electronic and software-based medical technologies.
The CTO will play a critical role in defining and delivering the company's technical roadmap, managing the end-to-end development of the device, and leading a growing R&D team.
Key Responsibilities:
* Lead the design, development, and validation of the electronic software medical device.
* Define and implement the technical strategy aligned with business goals.
* Build and manage a high-performing R&D and engineering team.
* Ensure full compliance with medical device regulations (e.g. ISO 13485, IEC 62304, FDA 21 CFR Part 820, EU MDR).
* Oversee system architecture, risk management, design controls, and quality assurance processes.
* Collaborate with executive leadership on strategic planning, product positioning, and technical communications with investors and partners.
* Manage external partnerships including contract developers, manufacturers, and consultants.
Requirements:
* Minimum 10 years' experience in the medical device industry, with a strong track record in R&D and product development.
* Hands-on experience in the development of electronic and software-based medical devices.
* Prior experience in a start-up or early-stage company environment is essential.
* Deep understanding of design control, product lifecycle management, and regulatory standards for medical devices.
* Strong leadership, team-building, and communication skills.
* Desirable experience leading multidisciplinary teams including software, hardware, and quality functions.
* Knowledge of cybersecurity and data privacy in connected health devices.
* Advanced degree in Biomedical Engineering, Electrical Engineering, or related field.
This is an excellent opportunity to join a dynamic team and contribute to the development of cutting-edge medical technology.