Fractional Chief Technology Officer (CTO)

Part-Time | 2–3 Days per Week | Hybrid Dublin - €800 - €1000 Per/ Day

An innovative early-stage medical device company is seeking an experienced Fractional (CTO) to lead technology and product development strategy through the next critical phases including design verification, First-in-Human (FIH) trials, regulatory submission (CE/510(k)), and market launch.

This role is initially part-time (2–3 days per week), with potential to grow into a full-time position as key milestones are achieved and further funding is secured.

Key Responsibilities

• Technical Leadership
• Define and drive the company’s technical and product development strategy aligned with clinical and regulatory milestones.
• Lead the development and iteration of the company’s implant system and supporting tools through pre-clinical, clinical, and commercial stages.
• Oversee design controls, risk management, and verification/validation processes.

• Team Management
• Build and lead a high-performing R&D and engineering team, including both internal staff and external development partners.
• Establish robust processes for quality assurance, risk management, and design control.

• Product & IP Development
• Oversee prototyping, design for manufacturability (DFM), and transfer to manufacturing partners.
• Guide the development and protection of the company’s intellectual property portfolio.

• Clinical & Regulatory Readiness
• Collaborate closely with clinical advisors and regulatory consultants to ensure engineering deliverables align with FDA and MDR requirements.
• Support clinical trial planning and execution, including FIH study design inputs and physician training tools.

• Strategic Leadership
• Contribute to fundraising, commercial planning, and investor relations as part of the executive leadership team.
• Represent the company in technical due diligence, partnerships, and at key industry forums

Experience and Skills

• Proven track record of bringing a Class II or III medical device from concept through clinical trials to market.
• Deep knowledge of design control, risk management, and human factors engineering within ISO 13485 and FDA/MDR frameworks.
• Experience in start-up or early-stage environments is highly desirable.
• Ability to work cross-functionally across clinical, regulatory, manufacturing, and commercial functions.
• Strategic mindset with a hands-on, problem-solving approach and comfort in a fast-paced environment.

Executive Search Specialising in Technology, Data, Software & Business Change, focusing on securing C-Suite executives & their direct reports across the IT Domain.

IT Specialist (CTO/ CEO/ CIO/CISO/COO/CDO/ Vice President (VP)/ Head of Engineering/ Software Development manager/ Director of Technology/ Director, Change & Transformation.

For a list of jobs:

https://www.archer.ie/#jobsearch

If you wish to discuss anything further, please do not hesitate to contact me on

01 6498506 or [email protected]