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
Business Development Manager (Pharma &am
Republic of Ireland
R&D Technician II
Galway
Responsible Person (RP)
Republic of Ireland
EHS Officer
Dublin
Design Assurance Engineer
Galway
Product Development Manager
Galway
R&D Manager
Galway
Electronic Engineer
Dublin
Documentation Specialist
Louth
Senior R&D Engineer
Galway
Senior R&D Manager
Athlone
Director of Quality Engineering
Limerick
Senior Quality Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Manufacturing Technician
Galway
Senior Electronic Engineer - Regulated M
Galway
Senior R&D Engineer
Clare
Senior Manufacturing Engineer
Galway City
Project Manager (hybrid)
Dublin
Principal Engineer
Dublin
Senior Electronic Engineer
Dublin
QA Engineer
Leitrim
EHS Officer
Dublin
R&D Scientist (Microbiology)
Wexford
R&D Director
Galway
Project Manager - R&D
Galway
Quality Technician
Dublin
Electronic Engineer
Dublin
Quality Assurance Specialist (Logistics)
Dublin
Advanced Technologies Manager
Galway
R&D Engineer
Galway
Process Engineer
Leitrim
Senior Regulatory Affairs Specialist
Clare
Biomedical Engineer
Dublin
R&D Manager
Connaught
Senior Manufacting Engineer
Republic of Ireland
R&D Engineer
Galway
Senior Operations Engineer
Galway
Senior Quality Engineer
Dublin
Quality Specialist
Tipperary
Electronic Engineer
Dublin
R&D Engineer
Dublin
QC Bioanalytical Sciences - Senior Assoc
Dublin
Project Manager - New Product Introducti
Dublin
Quality Assurance Team Lead
Cork
Engineering Shift Technician
Dublin
Injection Molding Engineer
North Leinster
Quality Manager
Dublin
Electronic Engineer
Dublin
Quality Manager - Medical Devices
Limerick City
Reg Affairs Specialist
Connaught
Quality Technician
Dublin
Value Stream Team Leader / Production Su
Wexford
Purchasing & Planning Manager
Wexford
Quality Manager
Dublin
Documentation Specialist
Louth
R&D Manager
Galway
Senior R&D Engineer
Galway
R&D Director
Galway
Staff R&D Engineer
Limerick
R&D Manager
Connaught
R&D Technician II
Galway
Senior Operations Engineer
Galway
R&D Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Documentation Specialist
Louth
Senior Maintenance Technician
Roscommon
R&D Manager
Galway
Senior Process Engineer
Dublin
Product Development Engineer
Dublin
Product Development Engineer
Dublin
Injection Moulding Engineer
Athlone
Injection Molding Engineer
North Leinster
Principal Engineer
Dublin
Purchasing & Planning Manager
Wexford
Quality Assurance Specialist (shift)
Carlow
Process Engineer
Galway
Engineering Support Specialist
Louth
Advanced Technologies R&D Manager
Clare
Principal Reliability Engineer
Galway
Senior Associate QC
Dublin
CTO
Dublin
Technical Life Cycle & Engineering M
Galway
Principal Design and Development Enginee
Galway
Senior R&D Manager
Athlone
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
R&D Manager
Athlone
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Senior Regulatroy Affairs Specialsit
Galway
Operations Engineer
Galway
R&D Engineer
Galway
R&D Director
Galway
Product Development Engineer
Dublin
Director
Clare
Product Development Engineer
Galway
Injection Molding Engineer
North Leinster
R&D Engineer
Clare
Regulatory Affairs Manager - Senior
Galway
Manufacturing Technician
Clare
R&D Director
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Dublin
Maintenance & Reliability Technician
Limerick
Principal R&D Engineer
Galway
R&D Engineer
Galway
Engineering Support Specialist
Louth
Senior Product Development Engineer
Galway
Quality Manager - NPI
Dublin
Quality Engineer
Galway
Senior Quality Engineer
Leitrim
Design Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior Quality Engineer
Galway
R&D Manager
Connaught
Senior Electronics Engineer
Dublin
Senior Electronic Engineer
Dublin
Product Specialist (Endoscopy)
Dublin
R&D Engineer
Galway
R&D Manager
Galway
Project Manager
Kildare
Quality Manager
Galway
Manufacturing Technician
Clare
Product Development Engineer
Dublin
CTO
Galway
Design Assurance Program Manager
Galway
Process Chemist
Limerick
Product Development Engineer
Dublin
Senior Quality Control Associate
Dublin South
Senior Project Engineer - R&D
Galway
Quality Engineer
Galway
Senior Engineering Manager
Limerick
Senior QA Associate (24/7 Shift)
Dublin
Manufacturing Technician
Clare
Principal Instrumentation & Calibrat
Limerick
Quality Manager
Galway
Principal R&D Engineer
Galway City
Quality Systems Manager
Dublin
Mechanical Technician
Carlow
Senior Electronic Engineer
Dublin
Microbiology Manager
Dublin
Quality Assurance Specialist (hybrid)
Dublin
R&D Manager
Dublin
Senior QC Associate - Data Analytics
Dublin
Senior Project Engineer
Cavan
Senior Process Engineer
Longford
Design Assurance Engineer
Galway
R&D Engineer
Galway
Mechanical Engineer
Dublin
Senior Electronics Engineer
Limerick
Sales/Customer Service Administrator
Clonmel
R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Athlone
Director of R&D
Limerick
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Senior Research & Development Engine
Limerick
Senior R&D Engineer
Dublin
Electronic Engineer
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Microbiologist
Dublin
QA Manager
Canada
Project Engineer
Cork
Principal R&D Engineer
Galway
R&D Manager
Connaught
Senior Research and Development Engineer
Galway
Manufacturing Technician
Clare
Process Engineer
Carlow
Senior QC Associate
Dublin
R&D Engineer
Dublin
Senior R&D Engineer
Clare
Principal Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Validation & Verification Engineer
Dublin
R&D Engineer
Galway
Project Engineer - Senior
Cavan
R&D Engineer
Galway
Senior Manufacturing Engineer
Galway
Senior Research and Development Engineer
Galway
Quality Engineer
Wexford
Principal R&D Engineer
Dublin
Design Assurance Program Manager
Galway
Contract Development & Manufacturing
Dublin
Warehouse Operator
Meath
Senior Quality Engineer
Dublin
Manufacturing Technician
Clare
R&D Engineer
Galway
Senior QC Associate
Dublin
Senior Equipment Design Engineer
Dublin
Quality Engineer
Galway
Senior Maintenance Technician
Kilkenny
Project Manager
Kildare
Electronic Engineering
Dublin
R&D Manager
Galway
Injection Molding Engineer
North Leinster
Quality Assurance Specialist (hybrid)
Dublin
Senior Regulatory Affairs Specialist
Athlone
Product Development Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Specialist
Clare
Product Development Engineer II
Athlone
Quality Engineer
Galway
Principal R&D Engineer
Galway
Senior Product Development Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
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 - SDA - Galway Location: Galway
Galway City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Biomedical Engineer, Design Assurance, Design Engineer, Lead Quality Engineer

Job title:Senior Design Assurance Engineer
Location:Parkmore Business Park, Galway.
Benefits:Excellent salary, bonus, pension, healthcare, hybrid working and opportunity to grow your career with hugely exciting Medical Device organisation.

Company:
My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that will focus initially on patients with Critical limb ischemia.


About the role:
As a Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross functional team for the design and development of sterile medical devices and /or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO 13485, CFR 820 and governing Regulatory Standards associated with the product classification. Lead the following activities from a quality perspective:


• Risk Assessments
• Device testing and associated validations
• Audits i.e. Critical Suppliers, Self-Inspections,
• On-going continuous improvement of the QMS
• Generation and /or approval of technical documents on behalf of the Quality Function.


Responsibilities:
- Responsible for compliance of product development and risk management activities with Medical Policies and Procedures and applicable Governing Regulatory Requirements.
- Work effectively as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc .
- Complete design verification, design validation and test method validation activities associated with product development activities.
- Works with R&D and Manufacturing Engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of appropriate production process monitoring activities.
- Support the resolution of project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Monitors compliance with Medical policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.


Requirements:
- Minimum Bachelor's Degree in Engineering, Science or related technical field.
- 4+ years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Ideally includes a minimum of 1 years in the QA activities associated with product design and development.
- Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016,the European Medical Device Regulations, the Canadian Medical Device Regulations and other international standards and regulations.
- Results and deadline driven with an ability to handle multiple tasks and operate in a fast paced environment..


Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]