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
R&D Technical Life Cycle & Engin
Galway
Injection Moulding Engineer
Athlone
QA Manager
Canada
Senior R&D Engineer
Galway
Senior Project Engineer - Utilities
Dublin
R&D Engineer
Galway
Senior Associate Quality Control
Dublin
Manufacturing Technician
Clare
R&D Director
Galway
Maintenance Reliability Engineer
Cork
Project Manager - R&D
Galway
Downstream Manufacturing Engineer
Dublin
R&D Manager
Connaught
CQV Engineer (CIP Start Up)
Denmark
Senior Maintenance Technician
Roscommon
Product Development Engineer
Galway
Microbiology Manager
Dublin
Staff R&D Engineer- Customer Focus
Dublin
Quality Engineer
Athlone
Senior Manufacting Engineer
Republic of Ireland
Product Development Technician II
Galway
Associate QA Specialist (Shift)
Carlow
R&D Manager
Connaught
CQV Lead
Tipperary
QC Separation Analyst
Cork
Quality Control NPI Senior Associate
Dublin South
Process Engineer
Cork
QA Engineer
Leitrim
Suite Team Delivery Lead
Tipperary
Technical Quality Assurance Specialist
Dublin
Manufacturing Engineer
Galway
Cleaning Validation Specialist
Cork
Validation Specialist
Cork
R&D Project Manager
Galway
Lead Project Engineer
Carlow
Senior Operations Engineer
Galway
Operational Excellence Specialist
Meath
QC Analyst - Analytical Testing
Meath
Senior Recruitment Consultant
Dublin
Biomedical Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Quality Engineer
Galway
Senior Validation Engineer
Carlow
Injection Molding Engineer
North Leinster
Injection Moulding Engineer
Athlone
Quality and Regulatroy Manager
Galway
Project Manager - R&D
Galway
R&D Engineer
Dublin
R&D Engineer
Galway
Project Engineer
Tipperary
Senior Manufacturing Engineer
Cork
Instrument Specialist
Tipperary
Senior Project Manager - Process Develop
Cork
Lead Maintenance Reliability Engineer
Westmeath
Manufacturing Engineer
Cork
E&I Turnover Engineer
Carlow
R&D Director
Galway
Technical Transfer Specialist
Cork
Senior Recruitment Consultant
Republic of Ireland
Project/Process Engineer - Purification
Cork
Specialist Operations Engineer
Tipperary
Senior Electrical Project Engineer
Dublin
Senior Validation Engineer
Limerick
Cleaning Validation Specialist
Cork
Product Development Engineer
Galway
Principal Process Development Engineer
Galway
Process Microbiologist
Cork
Electrical Engineer
Limerick
Chemical Engineer
Tipperary
Senior Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Electronic Design Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Commissioning and Qualification Engineer
Dublin
Manufacturing Engineer
Cork
QC Laboratory Technician
Carlow
Recruitment Consultant
Republic of Ireland
Senior Process Engineer
Cork
Software Design Assurance Engineer
Dublin
Production Operator
Dublin
Engineering Business Manager
Dublin
Senior Quality Engineer
Galway
Senior Product Development Engineer
Galway
Quality Engineer
Athlone
R&D Engineer
Galway
Product Development Engineer II
Athlone
Account Manager UK and Ireland
Republic of Ireland
Quality Validation Engineer
Limerick
Senior Equipment Design Engineer
Dublin
Validation Engineer
Limerick
R&D Manager
Connaught
Quality Specialist
Tipperary
Principal Heart Valves Engineer
Galway
Supply Chain Process Lead
Louth
R&D Project Manager
Galway
Senior Technical Transfer Engineer
Cork
Advanced Technologies Manager
Galway
Senior Engineering Manager
Limerick
Engineering Shift Technician
Dublin
R&D Manager
Athlone
Technical Specialist - Process Support
Cork
Reliability Engineering Specialist
Louth
Production Operator
Carlow
R&D Manager
Galway
Regional Program Coordinator - Global Le
Dublin
Project Manager
Limerick
Shift Technician (Injection Moulding)
Kildare
Senior Process Engineer
Cork
Senior R&D Engineer
Dublin
Principal Engineer
Dublin
Process Engineer (Shift)
Carlow
R&D Manager
Galway
Injection Moulding Engineer
Leitrim
Recruitment Consultant
Wexford
Senior QC 24/7 Shift
Dublin
R&D Manager
Connaught
Principal R&D Engineer
Galway
Senior Electronic Engineer
Dublin
Head of R&D
Galway
Process Engineer
Limerick
Senior Electrical Engineer
Galway
Senior R&D Engineer
Dublin
Principal Software Engineer
Athlone
Embedded Software Engineer
Dublin
Manufacturing Technician
Clare
Principal Process Equipment Engineer
Dublin South
Associate Director Clinical Regulatory S
Cork
CSV Engineer - IT Labs
Limerick
Clinical Research Program Manager
Galway
Senior Quality Engineer
Leitrim
Senior Design Assurance Engineer
Galway
NPI Process Engineer
Carlow
Process Chemist
Limerick
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Regulatroy Affairs Specialsit
Galway
Quality Manager
Dublin
C&Q Lead
Tipperary
Technical Life Cycle & Engineering M
Galway
Quality Systems Specialist
Cork
Project Engineer
Limerick
Manufacturing Technician
Clare
Mechanical Design Engineer
Germany
Senior HVAC Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Senior Technical Scientist - Technical T
Cork
R&D Director
Galway
Manufacturing Technician
Clare
Biostatistician
Dublin City Centre
Pharmacovigilance Manager (Remote)
Republic of Ireland
R&D Director
Galway
Senior Recruitment Consultant
Cork
Quality - Tech Transfer Specialist
Cork
Project Manager - R&D
Galway
Remote Process Engineer - Fill Finish
Republic of Ireland
Senior Regulatory Affairs Specialist
Athlone
Project Enginer
Dublin South
Business Development Executive
England
Senior Recruitment Consultant
Republic of Ireland
Senior Operations Engineer
Galway
Senior R&D Manager
Athlone
Change Control Lead
Tipperary
R&D Engineer
Clare
Process Support Specialist
Carlow
Senior Research and Development Engineer
Galway
Chief Medical Officer
Dublin
Cleaning Validation Specialist
Cork
Principal/Senior R&D Engineer Cathet
Galway
Senior R&D Manager/Director
Dublin
QA Supplier Specialist
Carlow
Quality Control Technician
Carlow
Senior Quality Engineer
Dublin
Quality Specialist & Deputy RP
Limerick
Compliance Specialist
Carlow
Quality Manager / PRRC
Dublin
E&I Turnover Engineer
Carlow
Senior Equipment Design Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Clare
Project Manager
Galway
Senior Quality Engineer
Leitrim
Quality Control Technician
Carlow
Product Lead
Dublin
Validation Engineer
Cork
Senior Electronics Engineer
Dublin
Biomedical Engineer
Dublin
Process Engineer
Galway
Manufacturing Project Engineer
Mayo
Senior Mechanical Engineer
Dublin
R&D Manager
Galway
Quality Auditor (Systems Specialist)
Tipperary
Engineering Projects Lead
Carlow
EHS Systems Specialist
Dublin
Project Engineer
Cork
Maintenance CMMS Engineer
Tipperary
R&D Engineer
Galway
Aseptic Process Lead
Carlow
Manager R&D
Connaught
Senior Project Engineer
Cavan
Senior Regulatory Affairs Specialist
Clare
Maintenance Engineer
Cork
Clinical Research Physician (CRP) and He
Cork
R&D Engineer
Galway
Manufacturing Engineer
Wexford
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Notified Body Product Assessor -Active D
Canada
CQV Engineer - SIP Start Up
Denmark
R&D Engineer
Clare
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Process Engineer - Water Formulations
Limerick
QC Associate Microbiology Specialist
Carlow
Principal Device Engineer
Dublin
Senior Validation Engineer
Dublin
Business Systems Director
Louth
Senior Regulatory Affairs
Galway
Quality Technician
Dublin
QC Bioassay Analyst
Carlow
R&D Lifecycle Manager
Connaught
Project Engineer
Republic of Ireland
R&D Manager
Galway
Product Development Engineer II
Athlone
Cleaning Validation Specialist
Cork
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Dublin
Senior Project Manager - Process Develop
Dublin
QA Manager
Canada
Injection Moulding Engineer
Athlone
Quality Engineer
Wexford
Associate Director Global Regulatory Aff
Cork
Senior Maintenance Technician
Carlow
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