Our client a high potential start-up are currently seeking a Senior Design Assurance Engineer to join their team. Reporting to the CTO the Senior Design Assurance will work with the core development team on a second generation delivery system. The Senior Design Assurance will join the team in the advancement of a nitinol implant with first and second generation delivery systems from design, manufacture, verification/validation testing, clinical trial and regulatory approval. Senior Design Assurance will have a hands-on approach to projects with a motivated attitude and strong work ethic. An ability to work and adapt in a flexible and fast paced environment is essential.


Role/Responsibilities


• Core part of the engineering team working on product design, development and testing of a novel device, from concept stage through to regulatory approval


• Work closely with clinicians, quality, regulatory and clinical to develop test programmes and test methods


• Liaise and support vendors during the prototyping and manufacture of device components, test fixtures and tooling


• Core participation in advancement from concept/prototype to manufacturing process development with a focus on development for successful device assembly and design verification testing and clinical use i.e. analysing, reducing and managing risks associated with the design, use, and manufacture of medical devices


• Conduct design verification bench testing of the device and device components


• Draft and compile technical documentation to support product development in accordance with the Medical Device Directive (MDD) and ISO 13485 Quality Management System


• Participate in the generation and maintenance of product Risk Management Files.





Skills and Experience:


• The successful candidate should be degree qualified in a relevant Engineering or Science discipline


• 4-5 years’ experience in medical device industry in a related role


• Project planning skills


• Excellent communication and writing skills


• Excellent mechanical design and understanding of engineering fundamentals with medical device materials knowledge, medical device polymers and nitinol behaviour


• Experience in medical device testing for regulatory compliance, risk management, design control in line with quality system requirements


• Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820)








For further information please contact James Cassidy james.cassidy@lifescience.ie or call 0860204322