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Senior Design Assurance Engineer

Location: Dublin
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Design Assurance

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.


• 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 or call 0860204322


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