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
R&D Manager
Connaught
QA Operations Specialist
Dublin
Regulatory Affairs Manager - Senior
Galway
R&D Engineer
Galway
Senior Operations Engineer
Galway
Engineering Business Manager
Dublin
Sterilisation Manager
Tipperary
Senior R&D Engineer
Galway
Quality Engineer
Wexford
Senior R&D Engineer
Dublin
Product Development Engineer
Dublin
Project Manager
Galway
Senior Regulatory Affairs Manager
Galway
Senior Design Assurance Engineer
Athlone
R&D Manager
Connaught
Business Development Manager
Republic of Ireland
Commercial Attribute Science Snr Associa
Dublin
Quality Manager
Dublin
Distribution Manager (Chemicals)
Dublin
Senior Process Development Engineer
Galway
Associate Director External Supply
Dublin
Senior Manufacturing Specialist
Dublin
R&D Engineer
Clare
Principal Quality Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Principal Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
R&D Engineer
Galway
Electronic Engineering
Dublin
Key Account Manager (Retail & Pharm
Dublin
R&D Manager
Galway
R&D Manager
Connaught
QA Manager
Canada
R&D Engineer
Galway
R&D Program Manager
Dublin
Key Account Manager - Retail UK National
South East
Senior Quality Engineer
Dublin
Quality Control Analyst (shift)
Carlow
Quality Assurance Specialist (shift)
Carlow
Senior Quality Engineer
Dublin
QA Engineer
Leitrim
R&D Manager
Galway
R&D Manager
Athlone
Senior Project Engineer
Dublin
Senior R&D Engineer
Dublin
Senior R&D Manager
Athlone
Senior Regulatory Affairs Specialist
Westmeath
Senior Design Assurance Engineer
Galway
Health & Safety Specialist
Louth
Industrial Designer
Galway
Manufacturing Technician
Clare
Project Manager - New Product Introducti
Dublin
Senior Principal R&D Engineer
Galway City
Quality Assurance Specialist/Manager
Dublin
Product Development Engineer
Dublin
R&D Manager
Dublin
Senior Electrical Engineer
Galway
Process Chemist
Limerick
CQV Engineer
Dublin
Senior Mechanical Engineer
Dublin
Senior Process Engineer - DP or DS
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Assurance Engineer
Longford
Business Development Manager (Hospitals)
Cork
Accreditation Manager
Republic of Ireland
Senior R&D Engineer
Galway
Continuous Improvement Coach
Limerick
Validation Engineer
Athlone
Process Development Engineer
Galway
R&D Manager
Galway
Marketing Manager
Galway
Biomedical Engineer
Dublin
Design Assurance Program Manager
Galway
Quality Engineer
Galway
Product Development Engineer
Galway
Manufacturing Technician
Clare
Engineering Support Specialist
Louth
Principal Design Assurance Engineer
Galway
Senior Maintenance Technician
Kilkenny
Production Operator
Meath
Senior Research & Development Engine
Limerick
Quality Assurance Specialist (Logistics)
Dublin
Sterilisation Manager
Tipperary
Bioprocess Associate
Louth
R&D Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
R&D Engineer
Dublin
Commercial Solutions Manager (Medical De
Dublin
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Senior Electronic Engineer
Dublin
Dental- Manager/ Senior Manager Business
Republic of Ireland
R&D Engineer
Galway
Quality Engineer
Galway
Supplier Quality Engineer
Galway
Senior Principal Design and Development
Galway
Project Manager
Kildare
Senior Equipment Engineer
Dublin
Product Development Manager
Galway
Warehouse Operator
Meath
Quality Technician
Dublin
Director of R&D
Limerick
Product Development Engineer
Galway
Senior Project Engineer
Cavan
Quality Assurance Team Lead
Cork
R&D Manager
Athlone
NPI Engineer - Hybrid
Dublin
Documentation Specialist
Louth
Senior Quality Engineer
Leitrim
Mechanical Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Quality Engineer - Supplier
Galway
Process Engineer
Galway
Senior Quality Engineer
Dublin
R&D Technician II
Galway
R&D Director
Galway
Process Development - Senior Project Man
Dublin
Quality Manager
Galway
Electrical Technician
Limerick
Manufacturing Technician
Clare
Responsible Person (RP)
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Clare
Project Manager (hybrid)
Dublin
Quality Specialist
Clare
Product Development Manager
Galway
Quality Engineer
Galway
Director of R&D
Clare
Project Manager (Pharma)
Dublin
R&D Engineer
Galway
Quality Engineer
Athlone
Principal Software Engineer
Athlone
CTO
Dublin
Senior Regulatory Affairs Specialist
Clare
Senior Quality Engineer
Dublin
R&D Director
Galway
Senior R&D Engineer
Galway
Project Manager
Kildare
Clinical Trial Manager
Republic of Ireland
Senior Maintenance Technician
Roscommon
Continuous Improvement Coach
Limerick
Principal Design Assurance Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Electronics Engineer
Dublin
R&D Manager
Galway
Senior Research and Development Engineer
Galway
Manufacturing Technician
Clare
Supply Chain Specialist - New Material I
Meath
Engineering Support Specialist
Louth
Laboratory Systems Specialist
Meath
(Senior) Manufacturing Engineers - Globa
Limerick
Principal Process Equipment Engineer
Dublin South
Calibration Technician
Republic of Ireland
Sr Principal R&D Engineer
Galway
Principal Reliability Engineer
Galway
R&D Technician
Galway
Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Technical Support Specialist - Drug Subs
Louth
Product Specialist (Endoscopy)
Dublin
Business Manager (Critical Care & Me
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Galway
Quality Control NPI Specialist
Carlow
R&D Manager
Connaught
Quality Engineer
Athlone
Quality Specialist
Tipperary
Manufacturing Technician
Clare
Quality Technician
Dublin
R&D Senior Program Manager
Galway
Senior QC Associate
Dublin
R&D Manager
Galway
Senior Regulatroy Affairs Specialsit
Galway
Senior Associate Quality Control
Dublin
Senior R&D Manager
Athlone
Quality Assurance Senior Specialist
Louth
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior Quality Assurance Technical Suppo
Dublin
R&D Engineer
Galway
Senior Process Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Senior Manufacting Engineer
Republic of Ireland
Senior Research Scientist
Galway
Principal R&D Engineer
Dublin
Senior Research Engineer
Galway
Project Engineer
Clare
Senior Contract Development & Manufa
Dublin
Injection Moulding Engineer
Athlone
Continuous Improvement Coach
Limerick
CTO
Galway
Product Development Engineer
Galway
Senior Equipment Design Engineer
Dublin
Supply Chain Specialist - SAP Master Dat
Meath
Equipment Engineer (Formulation, Autocla
Dublin
R&D Director
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Design Engineer
Dublin
Quality Engineer
Galway
Quality Manager
Galway
Quality Technician
Dublin
Manufacturing Engineer
Galway
Senior Operations Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Learning Systems Lead
Limerick
Application Software Engineer
Galway
Quality Engineer
Galway
Principal Design Assurance Engineer
Galway
R&D Lifecycle Manager
Connaught
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]