I'm looking for...
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
Job Tools
Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
Responsible Person (RP)
Republic of Ireland
Sales/Customer Service Administrator
Clonmel
Project Engineer
Clare
Biomedical Engineer
Dublin
R&D Manager
Galway
Senior Design Assurance Engineer
Galway
Downstream Investigations Specialist
Dublin
Senior Cleaning Validation Engineer
Carlow
Change Control SME
Cork
R&D Engineer
Galway
Senior Associate QC
Dublin
Senior R&D Project Manager
Galway
Senior Microbiologist
Dublin
Clinical Project Manager
Cork
Material Handler
Carlow
Staff R&D Engineer- Customer Focus
Dublin
Principal Engineer
Dublin
R&D Engineer
Galway
Product Development Engineer II
Athlone
Project Engineer
Limerick
Sr. Associate - Quality for Computer Sys
Cork
Senior Regulatory Specialist
Cork
Associate Director - Global Core Labelin
Cork
Quality Assurance Engineer
Longford
Biostatistician
Dublin City Centre
Maintenance Reliability Engineer
Tipperary
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Principal R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Associate Quality Control
Dublin
Manufacturing Engineer
Wexford
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Galway
Product Development Engineer II
Athlone
Process Engineer
Galway
Global Safety Senior Manager
Dublin
Senior R&D Engineer
Galway
CTO
Dublin
R&D Engineer
Galway
Principal Engineer
Dublin
QC Laboratory Technician (shift)
Carlow
R&D Manager
Dublin
Technical Transfer Specialist
Cork
Engineering Projects Lead
Carlow
Senior Process Development Engineer
Galway
EHS Systems Specialist
Dublin
Senior Quality Control Associate
Dublin South
Technical Services Manager
Tipperary
R&D Engineer
Galway
Senior Regulatory Specialist
Cork
QA Operations Specialist (Shift)
Dublin
Maintenance Technician
Carlow
Senior Quality Engineer
Galway
Manufacturing Engineer
Cork
Quality Specialist
Tipperary
Validation Engineer
Athlone
Utilities Engineer - Black Utilities
Roscommon
R&D Project Manager
Galway
Bioanalytical Senior Principal Scientist
Limerick
Senior Operations Engineer
Galway
Product Development Technician II
Galway
Quality Engineer
Galway
Quality Engineer
Athlone
Manufacturing Engineer
Galway
Senior R&D Engineer
Galway
Associate Director Global Regulatory Aff
Cork
Utilities Engineer
Dublin
Senior Quality Engineer
Leitrim
Senior R&D Manager/Director
Dublin
Validation Specialist - 50/50 remote
Carlow
Clean Utilities Engineer
Carlow
QC Laboratory Technician
Carlow
Quality Manager
Dublin
Manufacturing Engineer
Cork
Senior R&D Engineer
Galway
Project Engineer - Senior
Cavan
QC Bioanalytical Analyst
Dublin North
Manufacturing Technician
Clare
Senior Director Statistics Data and Anal
Cork
Account Manager UK and Ireland
Republic of Ireland
QA Manager
Canada
Senior Human Factors Engineer
Dublin
Validation & Verification Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
SAP Analyst - Logistics & Supply Cha
Limerick
Scientist (hybrid)
Meath
Head of R&D
Galway
Principal R&D Engineer
Galway
Senior Polymer Development Engineer
Galway
R&D Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Quality Engineer
Galway
Clinical Trial Quality Representative
Cork
Product Development Engineer
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
R&D Engineer
Galway
Principal Quality Engineer
Galway
Quality Specialist
Tipperary
Senior R&D Engineer
Galway
Senior Electronic Engineer
Dublin
Product Development Engineer
Dublin
Senior Design Engineer
Dublin
Electronic Design Engineer
Galway
Mechanical Design Engineer
Germany
Electronic Engineer
Dublin
MS&T Associate Director
Dublin
Electronic Engineer
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Associate Director Global Regulatory Aff
Cork
Quality Technical Services Manager - 12
Dublin
Senior Design Engineer
Dublin
Product Development Engineer
Dublin
Product Development Engineer
Dublin
Senior R&D Engineer
Clare
Product Development Engineer II
Athlone
Cleaning Validation Specialist
Cork
Senior R&D Engineer
Dublin
Applications Scientist
Dublin
Senior R&D Engineer
Galway
Maintenance CMMS Engineer
Tipperary
Process Chemist
Limerick
National Retail Sales Manager (Ireland)
Dublin
Senior Regulatory Affairs
Galway
Quality Manager
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Regulatory Affairs Associate
Cork
R&D Program Manager
Dublin
R&D Engineer
Galway
Chief Medical Officer
Dublin
NPI Process Engineer
Carlow
Technology Transfer Specialist
Meath
R&D Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Design Assurance Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
R&D Engineer
Dublin
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Senior Manufacting Engineer
Republic of Ireland
R&D Director
Galway
Product Development Engineer
Galway
QC Instrumentation Engineer
Limerick
R&D Manager
Athlone
Quality Engineer
Galway
Quality Engineer
Galway
Senior R&D Engineer
Clare
Senior Recruitment Consultant
Republic of Ireland
MS&T Bioprocess Engineer
Meath
Project Manager Design Assurance
Galway
Manufacturing Engineer
Galway
Sourcing Specialist
Tipperary
VP of Operations
Dublin
Advanced Technologies Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Electronic Design Engineer
Dublin
Principal Device Engineer
Dublin
Senior Electronic Engineer
Dublin
Senior Human Factors Engineer
Dublin
Senior Clinical Project Manager
Dublin
Quality Specialist
Clare
Principal Equipment Engineer
Dublin
Electronic Engineer
Dublin
R&D Manager
Connaught
Technical Life Cycle & Engineering M
Galway
R&D Manager
Connaught
Principal Equipment Engineer
Dublin
Notified Body Product Assessor -Active D
Canada
R&D Engineer
Galway
Senior QC Microbiology (24/7 Shift)
Dublin
Investigation Lead
Dublin
Manufacturing Biotech Associate 24/7 Shi
Meath
R&D Director
Galway
Senior R&D Engineer
Dublin
Senior Recruitment Consultant
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Compliance Specialist
Carlow
Quality Control NPI Senior Associate
Dublin South
NPI Process Engineer
Carlow
Senior Quality Engineer
Galway
Quality Control Technician
Carlow
Biomedical Engineer
Dublin
Microbiology Manager
Dublin
Production Operator
Dublin
R&D Engineer
Galway
QA Manager
Canada
R&D Manager
Athlone
Senior Associate Quality Control
Dublin
Advanced Technologies R&D Manager
Clare
Principal Preclinical Scientist
Galway
R&D Engineer
Galway
QA Engineer
Leitrim
R&D Engineer
Clare
Associate Director - Global Core Labelin
Cork
Senior Quality Engineer
Dublin
Principal Process Development Engineer
Galway
Quality Engineer
Galway
Quality Technician
Dublin
Principal Heart Valves Engineer
Galway
Senior Maintenance Technician
Roscommon
Senior Quality Engineer
Leitrim
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Manager
Athlone
Process Engineer (NPI)
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Senior Process Development Scientist
Dublin
Senior Process Engineer
Cork
R&D Director
Galway
Cleaning Validation Specialist
Cork
R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Regulatory Affairs Associate
Cork
Senior Quality Engineer
Leitrim
Maintenance Reliability Engineer
Cork
R&D Manager
Connaught
R&D Manager
Galway
Quality Engineer
Galway
Senior R&D Engineer
Dublin
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 [email protected]
Details

Senior Design Assurance Engineer


Reference:JCAO0721 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance

Senior Design Assurance Engineer

Our client a medical device company currently seeking a Design Assurance Engineer to join their team, The Design Assurance will be working in the Quality Assurance/Regulatory Affairs departmentteam responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.​


Role/Responsibilities:

  • Performs Design Assurance activities including technical reviews of design documentation and labelling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
  • Project manager EU MDR deliverables.
  • Support MDR projects as deemed necessary by the QARA Department
  • Quality approver on all relevant records, tests, validations, reports, project file entries etc.
  • Supports external audits including notified body and FDA audits.
  • Promotes the awareness of regulatory and customer requirements throughout the organization.
  • Perform standards gap analyses as required for MDR, R&D projects etc.
  • QA lead for Product design transfer/validation strategy development and implementation
  • Provide guidance and training for new hires and student engineers
  • Support new test development and appropriate test method validation
  • Lead data analysis best practice including sample planning, reporting and statistical analysis.
  • Implement updates to applicable quality system requirements.
  • Methodical review approach and be capable of initiating and leading change and continuous improvement.

Education/Experience:
  • A degree in Engineering, Technology or Science.
  • At least 5-7 years’ experience working in a regulated device or pharmaceutical company.
  • Excellent planning and coordination skills.
  • Excellent verbal and written communication skills.
  • Must have attention to detail for this Quality role.
  • Training in risk management, problem solving methods, design controls, validations, usability or biocompatibility would be advantageous.
​

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322