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
Colin Clare
Life Science

+353870608656
[email protected]
Connect with me on
Hot Science Jobs
Project Engineer - Senior
Cavan
Product Development Engineer II
Athlone
Project Engineer
Clare
Scientist (hybrid)
Meath
Technical Administrator
Tipperary
Senior R&D Engineer
Galway
R&D Manager
Dublin
Commisioning and Qualification Engineer
Cork
Injection Molding Engineer
North Leinster
Design Assurance Engineer
Clare
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Cleaning Validation Specialist
Cork
Process Safety Specialist
Tipperary
Senior Manufacting Engineer
Republic of Ireland
Senior Manufacturing Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Process Chemist
Limerick
Biomedical Engineer
Dublin
Senior Associate QC
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Project Engineer
Roscommon
Lead Manufacturing Technician
Kilkenny
Microbiologist
Cork
Quality Assurance Engineer
Longford
Senior Quality Systems Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs
Galway
Safety & Environmental Specialist
Carlow
EHS Specialist
Meath
Reg Affairs Specialist
Connaught
Senior Design Assurance Engineer
Clare
Senior Manager Bioanalytical QC Lab
Limerick
Operations Excellence Lead
Louth
Senior R&D Manager
Athlone
NPI Process Engineer
Carlow
Electronic Engineer
Dublin
Business Systems Director
Louth
Project Engineer
Cork
QC Systems Specialist
Dublin
Validation & Verification Engineer
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Product Development Engineer
Galway
Cleaning Validation Specialist
Carlow
Quality Specialist
Clare
Quality Engineer
Athlone
Injection Moulding Engineer
Leitrim
DeltaV Lead Automation Engineer
Tipperary
Biostatistician
Dublin City Centre
Regulatory Affairs Specialist
Cork
Embedded Software Engineer
Dublin
CTO
Dublin
Senior QC Microbiology
Dublin
R&D Project Manager
Galway
Engineering Projects Lead
Carlow
Senior R&D Engineer
Galway
Research Officer
Dublin
Utilities Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Athlone
Senior QA Associate (Shift)
Dublin
Senior Recruitment Consultant
Dublin
Senior Quality Systems Engineer
Galway
R&D Engineer
Galway
QA Manager
Canada
Medical Secretary
Cork
Project Engineer
Limerick
(Senior) Manufacturing Engineers - Globa
Limerick
R&D Engineer
Galway
Operations Engineer
Galway
R&D Manager
Connaught
Electronic Engineer
Dublin
Design Assurance Engineer
Galway
Senior R&D Engineer
Dublin
Project Engineer
Cork
QA Engineer
Leitrim
Senior R&D Manager - Lifecycle Manag
Galway
Senior Equipment Design Engineer
Dublin
Senior Process Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Project Manager
Galway
Project Manager - R&D
Galway
Quality Operations Manager
Dublin
R&D Engineer
Clare
Senior Design Assurance Engineer
Clare
Director of Quality Engineering
Limerick
Senior Design Assurance Engineer
Galway
Principal Engineer - R&D
Galway
Account Manager UK and Ireland
Republic of Ireland
Quality Engineer
Galway
R&D Lifecycle Manager
Connaught
Principal Process Development Engineer
Galway
Associate Director - Global Core Labelin
Cork
Product Development Technician II
Galway
Technical Transfer Specialist
Cork
R&D Program Manager
Dublin
QA Manager
Canada
VP of Operations
Dublin
Project Manager - R&D
Galway
Manufacturing Technician
Clare
Quality Manager
Dublin
Advanced Technologies R&D Manager
Clare
Manufacturing Project Engineer
Sligo
Lead Maintenance Reliability Engineer
Westmeath
Senior Design Assurance Engineer
Clare
Senior Quality Control Associate
Dublin South
R&D Engineer
Galway
Validation Engineer
Athlone
Senior Analytical Specialist
Limerick
Electronic Engineer
Dublin
Quality Engineer
Galway
Quality and Regulatroy Manager
Galway
Senior Project Engineer
Cavan
R&D Manager
Galway
R&D Technician II
Galway
R&D Engineer
Galway
Project Manager - R&D
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Head of R&D
Galway
R&D Engineer
Dublin
Product Development Engineer
Dublin
Quality Engineer
Athlone
Senior Recruitment Consultant
Republic of Ireland
R&D Engineer
Galway
R&D Director
Galway
Quality Technician
Dublin
Senior Technical Transfer Specialist
Cork
Senior Analytical Scientist
Cork
Advanced Technologies Manager
Galway
Process Simulation Technical Engineer
Carlow
Process Support Specialist
Carlow
Maintenance Technician
Kilkenny
Technology Transfer Specialist
Meath
CTO
Galway
Product Development Engineer
Dublin
Quality Technical Services Manager - 12
Dublin
Senior R&D Engineer
Galway
Senior Procurement Associate
Limerick
Senior R&D Engineer
Galway
Quality Engineer
Galway
Production Operator
Dublin
Production Operator
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Senior Equipment Design Engineer
Dublin
Manufacturing Biotech Associate 24/7 Shi
Meath
Quality Engineer
Galway
R&D Engineer
Galway
Graduate Manufacturing Technician
Kilkenny
Business Development Manager (Pharmacy)
Cork
Senior R&D Engineer
Clare
Project Manager Design Assurance
Galway
Quality Specialist
Tipperary
Clean Utilities Engineer
Carlow
Laboratory Systems Lead
Meath
Senior Electrical Engineer
Galway
Maintenance Technician
Carlow
Senior Project Manager - Process Develop
Cork
R&D Manager
Galway
Clinical Research Associate
Cork
R&D Engineer
Galway
QA Validation Specialist
Meath
Senior Equipment Design Engineer
Dublin
Technical Operations Specialist
Cork
Territory Sales Specialist (Life Science
Belfast City
R&D Manager
Connaught
Senior Electronic Engineer
Dublin
Quality Systems Manager
Dublin
Senior QC Microbiology (Shift)
Dublin
Project Engineer
Cork
Senior Quality Engineer-Remote
Republic of Ireland
Production Operator
Carlow
Senior Quality Engineer
Dublin
Quality Engineer
Galway
Change Control SME
Cork
R&D Engineer
Galway
Reg Affairs Specialist
Connaught
R&D Engineer
Galway
Production Operator
Dublin
Change Control Lead
Tipperary
Quality Director
Galway
Process Engineer
Cork
Quality Manager
Wexford
Maintenance Technician
Kilkenny
Senior Validation Engineer
Carlow
R&D Manager
Connaught
Senior R&D Manager
Athlone
Principal Data Architect
Limerick
EHS Systems Specialist
Dublin
Injection Moulding Engineer
Athlone
Manufacturing Engineer
Galway
Material Handler
Carlow
Senior Regulatory Specialist
Cork
Compliance Specialist
Carlow
R&D Manager
Athlone
Principal Software Engineer
Athlone
Principal Process Development Engineer
Dublin
Regulatory Affairs Associate
Cork
Senior Regulatroy Affairs Specialsit
Galway
Sourcing Specialist
Tipperary
NPI Process Engineer
Carlow
Manufacturing Engineer
Cork
Director of Regulatory Affairs
Galway
Senior Design Engineer
Dublin
Injection Molding Engineer
North Leinster
Manufacturing Engineer
Galway
Supply Chain Senior Associate (hybrid)
Dublin
Medical Writer
Cork
Senior R&D Engineer
Galway
Validation Specialist - 50/50 remote
Carlow
Cleaning Validation Specialist
Cork
R&D Director
Galway
Principal R&D Engineer
Galway
Production Operator
Meath
Strategic Automation Lead
Waterford
Quality Manager - NPI
Dublin
Senior Process Development Engineer
Galway
Product Development Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Quality Manager - Medical Devices
Limerick City
R&D Manager
Connaught
R&D Technician
Galway
Product Development Engineer II
Athlone
Product Development Manager
Galway
Senior Microbiologist
Dublin
R&D Manager
Galway
Quality Engineer
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Quality Technician
Dublin
Senior Recruitment Consultant
Republic of Ireland
Technical Specialist - Manufacturing Pro
Cork
Product Development Engineer II
Athlone
Project Manager - R&D
Galway
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
R&D Manager
Galway
Principal Scientist Device and Product P
Dublin
Quality Control Technician
Carlow
EHS Officer
Dublin
Lead Project Engineer
Carlow
R&D Engineer
Galway
Senior Research and Development 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

Software Design Assurance Engineer


Reference:CCL (AHPD-441806) Location: Dublin
Dublin City Centre
Dublin South
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, Design Engineer, EHS Engineer

Software Design Assurance Engineer

Our client in Dublin are looking to add a Software Design Assurance Engineer to their growing team.

Our client are a global medical technology company founded to establish bimodal neuromodulation as a new standard of care for tinnitus, a condition that affects 15% of the global adult population.

Main Purpose and Objective of the Position:

You will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software.

Responsibilities:

  • Provide Software Quality leadership for new product introductions and sustaining product development teams.
  • Work closely with Software development team on process optimization for efficient iterative generation and maintenance of regulatory deliverables.
  • Support the creation and review of all medical device software documentation including Software Development Plans, Design Specifications, Software Safety Classification, Software Design Verification Testing plans, protocols and reports, software issue tracking and resolution, cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.
  • Develop Test plans, and test cases based upon the product and component level requirements.
  • Understanding of all aspects of the QMS related to Design Controls.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the applicable regulations and standards, and internal company procedures.
  • Provide detailed assessments of impacts for design changes on commercialized products.
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Lead the creation and review of risk management files to include the risk management plan, product hazard analysis, FMEA’s, Risk Management Matrix, and Benefit Risk Determination.
  • Ensure Risk Management effectively integrates feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HRAs, etc. Familiarity with ISO 14971, Risk management for medical devices and IEC 62304 Medical Device Software. Understand and support all aspects of the QMS related to Design Controls.
  • Develop and report status of Quality and Reliability metrics during phase reviews.

Qualifications and Skills:
  • You have a bachelor’s degree or higher in a related field.
  • 3+ years in regulated work environment including at least 2 years in Medical Devices.
  • Technical expert with strong communication skills.
  • Experience with verification and validation (V&V) required.
  • Expert knowledge of IEC 62304 (Software Development Life Cycle).
  • Good working knowledge of ISO13485 and ISO14971.
  • IEC 62366 knowledge preferred (Usability).
  • Understanding of MDR and CFR requirements.
  • Prior experience with Jira/Structure/templated export or equivalent software tooling.

For further details please contact:Colin Clare on+353 87 060 8656or send CV to [email protected]