close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Senior Design Assurance Engineer


Reference:JCAO2412 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
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.


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