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
Principal Engineer
Dublin
Senior R&D Project Manager
Galway
Principal Quality Engineer
Galway
Principal Preclinical Scientist
Galway
Quality Control Technician
Carlow
Senior Associate QC
Dublin
Purchasing Specialist
Waterford
Technical Transfer Engineer - Drug Subst
Louth
Senior Regulatory Affairs Specialist
Clare
NPI Process Engineer
Carlow
Senior R&D Engineer
Dublin
Senior Electrical Engineer
Galway
Reliability Engineer
Tipperary
Project Manager - R&D
Galway
Injection Moulding Engineer
Athlone
Senior Quality Engineer-Remote
Republic of Ireland
Manufacturing Technician
Clare
Lead Maintenance Reliability Engineer
Westmeath
R&D Engineer
Clare
Senior R&D Engineer
Dublin
R&D Director
Galway
E&I Turnover Engineer
Carlow
Senior R&D Manager
Athlone
Quality Assurance Operations (Hybrid)
Meath
Process Chemist
Limerick
Senior R&D Engineer
Clare
Technical Sales Manager (Chemistry)
Westmeath
R&D Sustaining Manager
Galway
R&D Engineer
Galway
C&Q Lead
Tipperary
R&D Manager
Galway
Electrical Engineer
Cork
Maintenance Engineer
Cork
Technical Specialist - Manufacturing Pro
Cork
Technical Specialist - Manufacturing Pro
Cork
Senior R&D Engineer
Dublin
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Senior Validation Engineer
Carlow
Process Engineer (Shift)
Carlow
Senior Design Quality Engineer
Dublin
Product Development Engineer
Galway
R&D Manager
Galway
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Validation Engineer
Cork
R&D Manager
Connaught
R&D Senior Program Manager
Galway
Regional Program Coordinator - Global Le
Dublin
Project/Process Engineer - Purification
Cork
Senior Technical Scientist - Technical T
Cork
Senior Quality Assurance Specialist
Dublin
R&D Director
Galway
Senior R&D Engineer
Dublin
Senior E&I Maintenance Technician
Carlow
Senior Equipment Engineer
Dublin
Process Support Specialist
Carlow
Senior Electronics Engineer
Dublin
Quality - Tech Transfer Specialist
Cork
Downstream Manufacturing Engineer
Dublin
Engineering Business Manager
Dublin
Operations Specialist
Louth
Shift Technician (Injection Moulding)
Kildare
R&D Director
Galway
Maintenance Reliability Engineer
Tipperary
Quality Technician
Dublin
Quality Engineer
Athlone
Injection Molding Engineer
North Leinster
Senior Manufacturing Engineer
Cork
Project Engineer
Limerick
Product Development Engineer II
Athlone
R&D Technician
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Director Statistics Data and Anal
Cork
Senior Project Manager - Process Develop
Dublin
Senior Human Factors Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
E&I Turnover Engineer
Carlow
Principal Software Engineer
Athlone
QA Manager
Canada
Clean Utilities Engineer
Cork
Senior Design Engineer
Dublin
Medical Device Director
Republic of Ireland
Reliability Engineering Specialist
Louth
R&D Project Manager
Galway
Product Lead
Dublin
Quality Manager / PRRC
Dublin
Product Specialist - Surgical (Belfast/
Belfast City
Product Development Technician II
Galway
Manufacturing Engineer
Limerick
Senior QC 24/7 Shift
Dublin
Project Manager - Suite Lead
Tipperary
QA Engineer
Leitrim
Compliance Specialist
Carlow
Technical Quality Assurance Specialist
Dublin
R&D Manager
Galway
Project Manager - Capital Projects
Meath
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Principal Heart Valves Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
Quality Specialist
Tipperary
R&D Manager
Athlone
Material Handler
Carlow
Senior Electronic Engineer
Dublin
Biostatistician
Dublin City Centre
Engineering Shift Technician
Dublin
Manufacturing Specialist - Investigation
Dublin South
Project Manager - R&D
Galway
Product Development Manager
Galway
Clinical Research Physician (CRP) and He
Cork
Principal/Senior R&D Engineer Cathet
Galway
Upstream Manufacturing Process Specialis
Cork
Product Development Engineer
Galway
Senior Project Engineer
Cavan
R&D Manager
Connaught
Project Enginer
Dublin South
Manufacturing Project Engineer
Mayo
Associate Director Global Regulatory Aff
Cork
Senior Operations Engineer
Galway
R&D Manager
Connaught
Mechanical Design Engineer
Germany
Technical Specialist - Process Support
Cork
Clinical Trial Quality Representative
Cork
Recruitment Consultant
Republic of Ireland
QC Separation Analyst
Cork
Senior R&D Manager
Athlone
Project Engineer - Senior
Cavan
Senior Quality Engineer
Leitrim
Senior Recruitment Consultant
Republic of Ireland
Chief Medical Officer
Dublin
Responsible Person (RP)
Republic of Ireland
Business Manager (Pharma Chemicals)
Westmeath
Sales/Customer Service Administrator
Clonmel
Product Development Engineer
Dublin
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior Quality Engineer
Dublin
Injection Molding Engineer
North Leinster
Senior Maintenance Technician
Roscommon
Senior Quality Control Associate
Dublin South
Senior Associate Quality Control
Dublin
Senior Process Development Engineer
Galway
Validation Engineer
Carlow
Commissioning and Qualification Engineer
Dublin
Senior QC Associate
Dublin
Sr. Associate - Quality for Computer Sys
Cork
Recruitment Consultant
Wexford
Senior Quality Engineer
Leitrim
Strategic Automation Lead
Waterford
Remote Process Engineer - Fill Finish
Republic of Ireland
Mechanical Technician - 2 Cycle
Carlow
Manufacturing Project Engineer
Sligo
Senior Process Engineer
Cork
Cleaning Validation Specialist
Cork
R&D Engineer
Dublin
Injection Moulding Engineer
Athlone
Technical Administrator
Tipperary
Project Manager - R&D
Galway
Lead Project Engineer
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Assurance Engineer
Longford
Senior Process Engineer
Cork
Manager R&D
Connaught
R&D Manager
Galway
Project Manager - Capital Projects
Cork
Technology Transfer Specialist (Technica
Cork
Chief Medical Officer
Dublin
Chemical Engineer
Tipperary
Project Engineer
Clare
Senior Research and Development Engineer
Galway
Account Manager UK and Ireland
Republic of Ireland
Maintenance Engineer
Carlow
R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Project Manager
Limerick
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Production Operator
Carlow
R&D Engineer
Galway
Quality Engineer
Athlone
CQV Lead
Tipperary
Project Engineer
Tipperary
EHS Specialist
Carlow
Aseptic Process Lead
Carlow
R&D Lifecycle Manager
Connaught
Project Engineer
Roscommon
Quality Validation Engineer
Limerick
Principal R&D Engineer
Dublin
Operational Excellence Specialist
Meath
Senior Associate Quality Control NPI
Dublin
Cleaning Validation Engineer
Carlow
Quality Manager
Dublin
Associate Director Clinical Development
Cork
Head of R&D
Galway
Medical Science Liaison (MSL)
Dublin
Senior Manufacting Engineer
Republic of Ireland
EHS Systems Specialist
Dublin
Technical Specialist - Analytical &
Cork
Project Engineer
Republic of Ireland
Engineering Projects Lead
Carlow
Senior Quality Engineer
Leitrim
Production Operator
Carlow
R&D Engineer
Clare
Principal Device Engineer
Dublin
Process Engineer
Limerick
Quality Manager - NPI
Dublin
Senior HVAC Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Process Engineer - Water Formulations
Limerick
Director of Quality Engineering
Limerick
QA Manager
Canada
Associate QA Specialist (Shift)
Carlow
Quality Engineer
Wexford
Validation Engineer
Limerick
Process Engineer
Cork
Senior Polymer Development Engineer
Galway
R&D Engineer
Galway
Manufacturing Engineer
Galway
Quality Technician
Dublin
Process Development Engineer
Galway
Manufacturing Engineer
Cork
Manufacturing Biotech Associate 24/7 Shi
Meath
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