Our client a medical device start-up looking to hire a CTO who will be responsible for leading cross-functional project teams through the product development cycle from concept to design, validation and regulatory approval through to delivery of a fully developed product, ready for market. This position offers the opportunity to join the executive team in an exciting early stage company.
• Responsible for directing the design, development and testing of the device.
• Responsible for helping define the optimal route to market for the device including test method development, creation and execution of design verification protocols and reports to bring the product from concept to launch.
• Support business development, including all activities to help secure financing for the organisation
• Provide direct supervision of all R&D staff and manage external vendors/partners as necessary to develop new technology for product development process
• Define the R&D organizational structure and drive recruitment of new R&D staff, define most effective manner to build team for faced paced growth and long-term success of the company
• Demonstrate collaborative leadership, being able to lead across multiple functions, beyond R&D: quality assurance, product management/operations, regulatory affairs.
• Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability
• Reports directly to the CEO.
• B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines
• Minimum of ten (10) years of related experience in medical device mechanical design/product development
• Prior experience in cardiovascular/nitinol/delivery system medical products highly preferred
• Prior experience in a medical device start up preferred.
• Class III medical product development experience involving clinical trials highly preferred
• Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
• Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
• Demonstrated experience as a project and people manager with good supervisory and teamwork skills in a fast paced and challenging environment
• Strong problem-solving mindset
• Excellent organizational and time management skills
• Effectiveness to deliver in low-structured environments
Availability to travel is required
James Cassidy | Tel: +353 (0) 1 5079250