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.
 Google Chrome |
 Internet Explorer |
 Mozilla Firefox |
 Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Print this job
Send Job Spec
Share on LinkedIn
Share on Facebook
Share on Twitter
Waterford
Tipperary
Louth
Galway
Dublin
Leitrim
Tipperary
Dublin
Tipperary
Carlow
Galway
Denmark
Dublin
Clare
Cork
Athlone
Cork
Clare
Carlow
Republic of Ireland
Carlow
Carlow
Dublin
Clare
Clare
Galway
Limerick
Athlone
Galway
Galway
Dublin
Canada
Galway
Westmeath
Galway
Limerick
Galway
Dublin
Galway
Carlow
Dublin
Galway
Dublin
Limerick
Galway
Tipperary
Athlone
Dublin
Dublin South
Carlow
Galway
Galway
Connaught
Republic of Ireland
Wexford
Meath
Limerick
Germany
Galway
Galway
Galway
Carlow
Galway
Athlone
Carlow
Dublin
Athlone
Clare
Dublin
Dublin
Limerick
Republic of Ireland
Dublin South
Galway
Tipperary
Leitrim
Carlow
Limerick
Athlone
Westmeath
Connaught
Westmeath
Dublin
Galway
Westmeath
Limerick
Clare
Dublin City Centre
North Leinster
Galway
Dublin
Dublin
Carlow
Republic of Ireland
Dublin
Westmeath
Dublin South
Dublin
Tipperary
Dublin
Clare
Dublin
Longford
Connaught
Republic of Ireland
Athlone
Cork
Connaught
Clare
Galway
Wexford
Tipperary
Tipperary
Galway
Dublin South
Galway
Limerick
Carlow
Cork
Galway
Galway
Dublin
Galway
Dublin
Athlone
Athlone
Canada
Tipperary
Dublin
Carlow
Galway
Carlow
Dublin
Athlone
Limerick
Limerick
Dublin
Dublin
Carlow
Dublin
Dublin
Dublin
Carlow
Republic of Ireland
Carlow
Galway
Galway
Dublin
Republic of Ireland
Waterford
Dublin
Dublin
Republic of Ireland
North Leinster
Dublin
Galway
Galway
Carlow
Roscommon
Cavan
Tipperary
Tipperary
Republic of Ireland
Limerick
Athlone
Galway
Dublin
Galway
Connaught
Westmeath
Carlow
Dublin
Galway
Galway
Republic of Ireland
Cork
Galway
Dublin
Dublin
Dublin
Galway
Galway
North Leinster
Dublin
Dublin South
Dublin
Galway
Tipperary
Tipperary
Athlone
Republic of Ireland
Galway
Connaught
Wexford
Galway
Dublin
Roscommon
Leitrim
Dublin
Dublin
Tipperary
Dublin
Dublin
Galway
Galway
Clare
Carlow
Carlow
Republic of Ireland
Dublin
Galway
Carlow
Limerick
Leitrim
Carlow
Dublin
Limerick
Galway
Dublin
Leitrim
Galway
Carlow
Dublin
Dublin
Cavan
Cork
Galway
Dublin
Limerick
Dublin
Dublin
Carlow
Athlone
Carlow
Clare
Dublin
Leitrim
Galway
Wexford
Carlow
Carlow
Westmeath
Carlow
Galway
Westmeath
Tipperary
Galway
Dublin
Carlow
Republic of Ireland
Senior Design Assurance Engineer
| Reference: | JCAO122421 | Location: |
Galway |
| Qualification: | Degree | Experience: | 3-4 Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
Senior Design Assurance Engineer
Our client a Galway based Medical Device company currently seeks a Senior Design Assurance Engineer. Reporting to the Design Assurance Manager the successful candidate will be focused on the development of new technologies
Role/Responsibilities
Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
Support the development / evolution of the Design Control, Risk Management and associated systems, to encompass new product development technologies.
Provide Design Assurance input to R&D project teams for designated projects Ø Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
Lead in specification development in relation to design input development. Participate in the generation of Design Input / Output documents.
Lead the risk management activities for designated projects and design changes.
Design, development and validation of test methods as required to support development programs.
Develop and maintain design verification and validation plans, protocols and reports. Ø Support R&D in the preparation and delivery of Design Reviews and associated checklists. Ø Support the execution of non-clinical studies at third party facilities, in conjunction with R&D department.
Establish and maintain the Design History File and associated documents.
Provide QA support to R&D for equipment management
Execute assigned aspects of the project, as required.
Mentor and support Design Assurance engineers.
Ensure assigned areas are in a state of readiness for unannounced and planned audits.
Act as a design assurance representative during audits of areas of assigned responsibility.
Bring effective closure to non-conformances highlighted.
Support sustaining activities as assigned.
Skills/Experience
A degree level qualification in Engineering, Science or related field is required.
Upwards of 5 years’ relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology experience.
An understanding of ISO13485, ISO14971 and FDA QSRs is a prerequisite.
Familiarity with statistics, validation and physical testing is required.
Good communication and organizational skills, and the ability to present reports neatly and accurately is essential.
For further information please contact James Cassidy [email protected] or call 0860204322
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
