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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For more info see Skills: CTO R&D Director Product Development Leadership