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
Senior Validation Engineer
Dublin
Project Manager
Kildare
Quality Engineer
Galway
Cleaning Validation Specialist
Cork
R&D Manager
Galway
Principal Process Equipment Engineer
Dublin South
R&D Manager
Connaught
Regulatory Affairs Maanger
Galway
R&D Engineer
Dublin
Purchasing & Planning Manager
Wexford
Manufacturing Technician
Clare
Senior R&D Engineer
Dublin
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
CTO
Dublin
MS&T Bioprocess Engineer
Meath
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Quality Engineer
Leitrim
Product Development Technician II
Galway
Process Engineer - MS&T (Hybrid)
Dublin
Electronic Engineer
Dublin
Senior Electronic Engineer - Regulated M
Galway
Senior Equipment Design Engineer
Dublin
Calibration Technician
Republic of Ireland
Senior Process Engineer
Dublin
Injection Moulding Engineer
Athlone
Quality Technical Services Manager - 12
Dublin
Quality Engineer
Galway
Production & Logistics Planner
Galway
Quality Engineer
Galway
Business Manager (Woundcare, Orthopaedic
Dublin
Senior Manufacting Engineer
Republic of Ireland
R&D Manager
Galway
Project Manager
Galway
Senior Maintenance Technician
Kilkenny
Senior Process Development Engineer
Galway
Senior R&D Engineer
Galway
Maintenance CMMS Engineer
Tipperary
Senior Regulatory Specialist
Cork
Process Chemist
Limerick
Principal Design and Development Enginee
Galway
R&D Technician II
Galway
Product Development Manager
Galway
Injection Molding Engineer
North Leinster
Project Manager - R&D
Galway
Strategic Automation Lead
Waterford
Principal Instrumentation & Calibrat
Limerick
Cleaning Validation Specialist
Cork
Health & Safety Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Warehouse Operator
Meath
R&D Manager
Athlone
Electronic Engineer
Dublin
Senior Engineering Manager
Limerick
Quality Engineer
Galway
Quality Manager
Dublin
Responsible Person (RP)
Republic of Ireland
CAPA Specialist
Cavan
R&D Manager
Galway
Quality Specialist
Tipperary
R&D Engineer
Galway
Warehouse Operator
Meath
Manufacturing Engineer
Galway
R&D Technician II
Galway
Senior Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior Design Engineer
Dublin
Senior Project Engineer
Cavan
Product Development Manager
Galway
Electronic Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Senior Electronics Engineer
Limerick
Electronic Engineer
Dublin
R&D Director
Galway
Senior Electronic Engineer
Dublin
Project Manager
Louth
Quality Engineer
Athlone
Project Manager Design Assurance
Galway
Senior Regulatory Affairs Specialist
Athlone
Documentation Specialist
Louth
Manufacturing Engineer
Galway
Senior R&D Engineer
Galway
QA Manager
Canada
Procurement Associate
Dublin
R&D Manager
Athlone
R&D Manager
Galway
Product Development Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Dublin
R&D Engineer
Galway
Process Engineer
Dublin
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Dublin
R&D Engineer
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
R&D Engineer
Galway
Quality Specialist
Clare
Senior R&D Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
R&D Technician
Galway
Quality Engineer
Galway
Technology Transfer Specialist
Meath
Purchasing & Planning Manager
Wexford
R&D Manager
Connaught
Senior Quality Control Associate
Dublin South
Quality Assurance Senior Specialist
Louth
Quality Manager - Medical Devices
Limerick City
Quality Engineer
Athlone
Staff R&D Engineer
Limerick
Advanced Technologies Manager
Galway
Senior Quality Systems Engineer
Galway
Maintenance & Reliability Technician
Limerick
Injection Molding Engineer
North Leinster
Quality Technician
Dublin
Quality Specialist
Clare
Project Engineer
Limerick
Manufacturing Project Engineer
Mayo
Senior Recruitment Consultant
Republic of Ireland
Account Manager (Chemicals) - Dublin
Dublin
R&D Engineer
Galway
Product Development Technician II
Galway
Documentation Specialist
Louth
Senior Regulatory Specialist
Cork
Senior R&D Engineer
Galway
R&D Program Manager
Dublin
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Westmeath
Senior R&D Manager
Athlone
Documentation Specialist
Louth
Senior Quality Engineer
Dublin
Maintenance Reliability Engineer
Cork
Senior R&D Engineer
Galway
Senior Electronic Engineer
Dublin
R&D Senior Program Manager
Galway
Injection Moulding Engineer
Athlone
DeltaV Technical Coordinator - Hybrid
Tipperary
Injection Moulding Engineer
Leitrim
Senior R&D Engineer
Galway
Senior Manufacturing Engineer
Galway
QA Engineer
Leitrim
Quality Assurance Associate
Cork
Senior Operations Engineer
Galway
Product Development Engineer II
Athlone
R&D Director
Galway
Software Design Assurance Engineer
Dublin
Senior Operations Engineer
Galway
Regulatory Associate
Cork
Senior Regulatory Affairs Specialist
Athlone
Manufacturing Engineer
Galway
Principal Quality Engineer
Galway
Clinical Project Manager
Cork
Senior Quality Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Project Engineer - Senior
Cavan
Manufacturing Technician
Clare
R&D Engineer
Galway
Maintenance & Reliability Technician
Limerick
Electronic Engineering
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
CTO
Galway
Operational Excellence Specialist
Cork
Quality Specialist
Clare
Manufacturing Technician
Clare
Senior Quality Engineer
Dublin
E&I Turnover Engineer
Carlow
R&D Engineer
Galway
R&D Manager
Connaught
Technical Specialist (Hybrid)
Cork
Regulatory Affairs Associate
Cork
Continuous Improvement Coach
Limerick
Associate Analytical Scientist
Meath
Biomedical Engineer
Dublin
Senior R&D Engineer - Sustaining
Galway
Senior Quality Engineer
Dublin
Operations Supervisor - Evening Shift (M
Sligo
R&D Engineer
Clare
R&D Manager
Galway
Shift Technician (Injection Moulding)
Kildare
R&D Director
Galway
Senior Research and Development Engineer
Galway
Project Manager
Kildare
Product Development Engineer
Dublin
Principal R&D Engineer
Dublin
Process Engineer
Galway
Senior R&D Engineer
Galway
Clinical Research Associate
Cork
Senior R&D Engineer
Galway
Senior Recruitment Consultant
Dublin
Mechanical Technician
Carlow
Site Microbiologist
Republic of Ireland
DeltaV Lead Automation Engineer
Tipperary
Validation Engineer
Athlone
Electronic Engineer
Dublin
Quality Engineer
Athlone
Quality Engineer
Galway
Production Operator
Meath
R&D Engineer
Galway
Quality Specialist (Shift)
Dublin
R&D Manager
Connaught
R&D Engineer
Galway
Electronic Engineer
Dublin
Program Manager
Dublin
Engineering Support Specialist
Louth
Advanced Technologies R&D Manager
Clare
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