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
Thomas Gallagher
Life Science

+353870612325
[email protected]
Connect with me on
Hot Science Jobs
Quality Specialist
Tipperary
Tech Transfer Lead
Dublin
R&D Director
Galway
Senior R&D Manager
Athlone
Dental Consultant- Manager/ Senior Manag
Republic of Ireland
Product Development Engineer
Galway
Project Engineer
Roscommon
Senior R&D Engineer
Dublin
R&D Manager
Connaught
Senior Quality Assurance Associate
Dublin
Quality Technician
Dublin
Quality Technician
Dublin
R&D Lifecycle Manager
Connaught
Production Manager
Wexford
Senior Regulatory Affairs Specialist
Westmeath
R&D Engineer
Dublin
Calibration Technician
Republic of Ireland
QA Specialist
Carlow
Senior Director of Manufacturing and Sup
Galway
Senior R&D Manager - Lifecycle Manag
Galway
CTO
Galway
Senior Quality Assurance Engineer
Galway
Strategic Automation Lead
Waterford
Distribution Partner Manager (Life Scien
Dublin
R&D Engineer
Galway
Quality Technician
Galway
Quality Manager
Galway
Responsible Person (RP)
Republic of Ireland
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Senior Project Manager
Meath
Senior Regulatory Affairs Specialist
Clare
R&D Manager
Dublin
Senior Manufacturing Engineer
Cork
Senior Quality Engineer
Dublin
Quality Assurance Specialist
Waterford
Senior QC Microbiology
Dublin
Process Chemist
Limerick
Shift Technician (Injection Moulding)
Kildare
R&D Engineer
Galway
Principal R&D Engineer
Galway
Analytical Science Associate & Speci
Carlow
EHSS Specialist (Construction & Comm
Athlone
Quality Systems Manager
Dublin
Senior Quality Engineer
Leitrim
Senior Electronic Engineer
Limerick
Senior Project Engineer
Cavan
R&D Director
Galway
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Product Development Manager
Galway
Endoscope Service Technician (Dublin)
Dublin
Principal Engineer
Dublin
R&D Manager
Athlone
Senior Reg Affairs Specialist - Post Mar
Galway
Senior NPI Engineer
Dublin
Website Audit Specialist
Dublin
Principal Engineer
Dublin
Senior Engineering Manager
Galway
Quality Manager
Galway
Senior Manufacturing Engineer
Galway City
R&D Manager
Athlone
A.I Specialist
Galway
Senior Engineering Manager
Galway
Senior Quality Engineer
Dublin
Principal Design and Development Enginee
Galway
Regulatory Affairs Manager - Senior
Galway
Industrial Engineer Capacity Planning
Dublin
Senior Quality Engineer
Dublin
Production Manager
Dublin
Quality Assurance Team Lead
Cork
Product Development Engineer II
Athlone
R&D Technician II
Galway
R&D Engineer
Galway
Mechanical Technician
Carlow
Operations Manager
Galway
Principal Reliability Engineer
Galway
Senior Project Engineer
Cavan
Product Development Engineer
Dublin
Senior Electronics Engineer
Limerick
Senior Process Development Engineer
Galway
Biomedical Engineer
Dublin
UK Based-EAP Portfolio Manager-Remote
United Kingdom
Senior Quality Engineer
Dublin
Senior Regulatory Affairs Manager
Galway
Quality Specialist
Clare
Reg Affairs Specialist
Connaught
Lead MSAT Validation Consultant
Republic of Ireland
R&D Manager
Connaught
Quality Assurance Manager
Galway
Quality Engineer
Galway
Quality Engineer
Wexford
EHS Specialist II
Limerick
Learning Systems Lead
Limerick
LIMS Specialist
Tipperary
Senior Mechanical Engineer
Dublin
Senior R&D Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Process Engineer - DP or DS
Dublin
R&D Engineer
Galway
Senior Engineering Manager
Galway
Warehouse Operator
Dublin
Senior QC Specialist
Dublin
Embedded Software Engineer
Dublin
Manufacturing Specialist - Investigation
Dublin
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Quality Assurance Associate
Dublin
Clinical Sales Specialist (Histology)
Dublin
Supply Chain Specialist - New Material I
Meath
Injection Moulding Engineer
Leitrim
Senior Regulatory Affairs
Galway
Principal R&D Engineer
Dublin
Design Assurance Program Manager
Galway
Senior R&D Engineer
Limerick
R&D Engineer
Dublin
R&D Engineer
Galway
Senior Electronic Engineer
Dublin
Senior Design Assurance Engineer
Galway
Quality Manager - Medical Devices
Limerick City
R&D Manager
Galway
Senior Product Development Manager
Galway
Health & Safety Specialist
Dublin
Senior Design Assurance Engineer
Galway
Senior Design Assurance Engineer
Galway
Documentation Specialist
Louth
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
Quality Engineer - Supplier
Galway
Senior Principal Design and Development
Galway
Director Engineering & Supply Chain
Galway
Technical Life Cycle & Engineering M
Galway
Project Manager
Kildare
R&D Manager
Connaught
Product Specialist (Critical Care &
Dublin
R&D Director
Galway
CTO
Dublin
Senior Quality Engineer
Leitrim
Project Manager
Dublin
Senior Quality Engineer
Dublin
Business Development Manager
Republic of Ireland
R&D Engineer
Clare
Senior R&D Engineer
Dublin
QA Manager
Canada
Quality Assurance Specialist (shift)
Carlow
Senior Regulatory Affairs Specialist
Dublin
Quality Manager
Galway
Calibration Planner & Scheduler
Carlow
Senior Microbiologist
Dublin
Senior NPI Engineer - Hybrid
Dublin
Director of R&D
Limerick
Senior Design Assurance
Galway
Senior QC Microbiology
Dublin
Biomedical Engineer
Dublin
Electronic Engineering
Dublin
R&D Program Manager
Dublin
Capital Specialist (Laboratory Equipment
Tipperary
Senior Quality Control Associate
Dublin South
Inside Scientific Sales Specialist
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality and Regulatory Affairs Manager
Dublin
Production Planner
Kildare
Senior Quality Engineer
Leitrim
Senior Quality Assurance Technical Suppo
Dublin
Senior QC Analyst
Republic of Ireland
Process Scientist MSAT
Louth
EHSS Specialist
Athlone
R&D Technician
Galway
Senior Equipment Design Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Senior R&D Engineer
Galway
Design Assurance Engineer
Galway
Senior Project Design Engineer
Limerick
Product Specialist (Critical Care &
Dublin
R&D Manager
Galway
Injection Moulding Engineer
Athlone
Senior R&D Engineer
Galway
Product Specialist (Critical Care &
Dublin
Senior Design Assurance Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Advanced Technologies Manager
Galway
Quality System & Regulatory Affairs
Galway
Quality Control Analyst (Cell Culture)
Carlow
R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Quality Manager
Galway
Operational Excellence Lead
Dublin
Project Manager
Kildare
EAP Portfolio Manager
Republic of Ireland
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Specialist MS&T
Dublin
Senior Design Engineer
Dublin
Product Development Technician II
Galway
Quality Manager
Galway
Key Account Manager (Hospital Pharmacies
Offaly
R&D Manager
Galway
Quality Manager
Galway
CQV Engineer
Roscommon
Quality Assurance Specialist (Hybrid)
Dublin
Senior Design Engineer
Dublin
Digital & Technology Manager
Dublin
Senior R&D Engineer
Dublin
QA Engineer
Leitrim
R&D Director
Galway
Senior Electronic Engineer
Limerick
Senior Research & Development Engine
Limerick
Senior Regulatory Affairs Specialist
Athlone
Quality Engineer - Supplier
Galway
Senior Maintenance Technician
Kilkenny
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Limerick
Process Engineer - Sterile Drug Product
Waterford
Quality Assurance Specialist
Carlow
Senior Project Engineer - R&D
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Regulatory Affairs Manager- Remote
Republic of Ireland
Design Quality Engineer
Galway
Process Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Quality Manager
Galway
Senior Quality Systems Engineer
Galway
Senior QC Associate - Equipment & I
Dublin
Senior Equipment Engineer
Dublin
Principal R&D Engineer
Galway
Manufacturing Technician
Clare
Product Development Engineer II
Athlone
Group Head of Commercial
Dublin
Senior Operations Engineer
Galway
Microbiology Manager
Dublin
Senior Maintenance Technician
Kilkenny
Senior R&D Engineer
Clare
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Specialist
Clare
Senior Design Engineer
Dublin
Laboratory Technician (Microbiology &
Dublin
Analytical Chemist
Tipperary
R&D Manager
Galway
R&D Manager
Galway
Senior QA Associate (shift)
Dublin
Principal Engineer
Dublin
Senior R&D Engineer
Galway
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:TG - DA - Oranmore Location: Galway
Galway City
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, Design Engineer

Role:Senior Design Assurance Engineer
Location: Oranmore, Galway (Hybrid working)
Benefits: Excellent salary, pension, healthcare, yearly bonus and share options.


Company:
My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and supporting complaint investigations to uphold the safety and effectiveness of our devices


Requirements:

  • 3-4 years experience (can be from MNC or start up)
  • Bachelor’s degree (Level 8 NFQ)

  • Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents.
  • Experience with design control and risk management throughout the product lifecycle,
  • Experience with post-market surveillance, complaint investigations, and CAPA systems



Day to day responsibilities:

  • Support sustaining commercial projects from a Design Assurance perspective
  • Lead and execute product / material design changes for commercially released products in accordance with regulatory and internal quality system requirements

  • Provide DA technical direction / input to process changes for commercially released products in conjunction with R&D and Manufacturing Engineering.

  • Maintain and update the risk management file for post-market products
  • Generation of Design Verification (DV) plans, protocols & reports and execution of DV testing to support product / material design changes and collection of shelf-life data to support regulatory submissions.
  • Ensure continued design control compliance (per FDA 21 CFR 820.30 and ISO 13485), including design history file (DHF) maintenance, verification/validation planning, and traceability.
  • Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA).




Would you be interested in seeing the full spec for the role? If you are interested in discussing further let me know and I am happy to have a call.