Job Title: Chief Technical Officer (CTO)
Location: Galway- Hybrid / On-site
Job Type: Full-Time | Permanent
Company Overview
My client, an early-stage medical device start-up focused on developing a next-generation electronic software medical device are entering an exciting phase of growth and are seeking a highly motivated and experienced Chief Technical Officer (CTO) to lead their technical strategy and execution.
Role Summary
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. 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.
Key Responsibilities

• Lead the design, development, and validation of the company's 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.

Required Experience

• 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.

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