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
Quality Engineer
Wexford
Senior Principal Design and Development
Galway
Senior Regulatory Affairs Specialist
Athlone
Sr Electrical Engineer
Galway
Sr Electrical Engineer
Galway
Injection Molding Engineer
North Leinster
Director of Quality Engineering
Limerick
Senior R&D Engineer
Clare
Senior Electronic Engineer - Regulated M
Galway
Senior Quality Engineer
Dublin
Quality Engineer
Galway
Biomedical Engineer
Dublin
Injection Molding Engineer
North Leinster
R&D Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Technician II
Galway
Quality Engineer
Galway
Senior R&D Engineer
Dublin
Senior Quality Engineer
Leitrim
Project Manager - R&D
Galway
R&D Engineer
Galway
Senior R&D Engineer
Clare
Engineering Support Specialist
Louth
R&D Engineer
Clare
Principal R&D Engineer
Galway
Product Development Engineer
Dublin
Principal Process Equipment Engineer
Dublin South
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Senior R&D Engineer
Galway
R&D Manager
Galway
Electronic Engineer
Dublin
R&D Director
Galway
Analytical Scientist
Meath
Quality Specialist
Clare
Quality Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
Technical Life Cycle & Engineering M
Galway
Senior Quality Assurance Specialist (Shi
Dublin
R&D Engineer
Galway
Senior Regulatory Specialist
Cork
Technology Transfer Specialist
Meath
Procurement Executive
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Software Design Assurance Engineer
Dublin
R&D Engineer
Galway
Maintenance & Reliability Technician
Limerick
QA Manager
Canada
Design Quality Engineer
Galway
CTO
Galway
Lead Maintenance Technician
Kilkenny
Project Manager (hybrid)
Dublin
Change Control SME
Cork
Senior Technical Transfer Specialist
Cork
Project Manager - R&D
Galway
Senior Design Assurance Engineer
Athlone
R&D Manager
Galway
Electrical Technician
Limerick
R&D Manager
Galway
Manufacturing Technician
Clare
R&D Manager
Galway
Senior Quality Engineer
Galway
Electronic Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Principal Research and Development Engin
Galway
Project Manager Design Assurance
Galway
Mechanical Technician
Carlow
Value Stream Team Leader / Production Su
Wexford
Quality Assurance Specialist (Logistics)
Dublin
Process Chemist
Limerick
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Equipment Engineer
Dublin
Project Manager - R&D
Galway
Design Assurance Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Tech Transfer Specialist
Meath
Electrical Condition Monitoring Technici
Limerick
Sr Electrical Engineer
Galway
Customer Services Specialist (Pharmaceut
Dublin
QA Engineer
Leitrim
Senior Manufacturing Engineer
Galway
R&D Manager
Dublin
Senior Project Engineer
Cavan
Principal Engineer
Dublin
Project Manager
Galway
Senior R&D Engineer
Galway
Product Development Engineer II
Athlone
Senior Regulatory Affairs Specialist
Athlone
Warehouse Operator
Meath
E&I Turnover Engineer
Carlow
Senior Process Development Engineer
Galway
Process Development Engineer
Galway
Principal Instrumentation & Calibrat
Limerick
Cleaning Validation Specialist
Cork
Quality Technician
Dublin
Project Manager
Kildare
Quality Specialist
Clare
Customer Services Manager (Pharmaceutica
Dublin
Advanced Technologies R&D Manager
Clare
Senior Recruitment Consultant
Dublin
Clinical Research Associate
Cork
Electronic Engineer
Dublin
Quality Engineer
Galway
Quality Technician
Dublin
Senior R&D Engineer - Sustaining
Galway
Injection Moulding Engineer
Athlone
Quality Technician
Dublin
Project Manager - R&D
Galway
Quality Specialist
Tipperary
Senior R&D Engineer
Galway
R&D Engineer
Galway
Strategic Automation Lead
Waterford
Project Manager
Kildare
Product Development Engineer
Dublin
Calibration Technician
Republic of Ireland
Project Manager Design Assurance
Galway
Senior Operations Engineer
Galway
Senior Process Engineer
Dublin
Injection Moulding Engineer
Athlone
Senior Regulatory Affairs Specialist
Clare
Project Engineer
Limerick
Senior Electronic Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Production Operator
Meath
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Product Development Engineer
Dublin
Product Development Engineer
Galway
Senior Engineering Manager
Limerick
Manufacturing Engineer
Galway
R&D Engineer
Galway
Process Engineer
Dublin
Cleaning Validation Specialist
Cork
Principal R&D Engineer
Galway
Product Development Engineer
Dublin
Maintenance CMMS Engineer
Tipperary
Product Development Technician II
Galway
CTO
Dublin
Quality Engineer
Galway
R&D Director
Galway
Quality Assurance Specialist (hybrid)
Dublin
R&D Manager
Connaught
R&D Manager
Athlone
Senior Design Engineer
Dublin
Quality Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Senior Product Development Engineer
Galway
Biostatistician
Dublin
Quality Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Manager
Galway
Senior Electronic Engineer
Dublin
Project Engineer
Cork
R&D Engineer
Galway
Senior R&D Engineer
Galway
Maintenance Reliability Engineer
Cork
R&D Engineer
Galway
Senior Quality Systems Engineer
Galway
Quality Engineer
Galway
Site Microbiologist
Republic of Ireland
Business Manager (Woundcare, Orthopaedic
Dublin
Principal Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Lead Chemistry Analyst
Cork
Senior Validation Engineer
Dublin
R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Sr R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Project Engineer
Clare
MS&T Scientist - AKTA systems
Meath
Project Engineer
Roscommon
Program Manager
Dublin
R&D Manager
Connaught
Regulatory Affairs Associate
Cork
Validation Engineer
Athlone
Clinical Research Associate
Cork
Senior Recruitment Consultant
Republic of Ireland
Quality Assurance Engineer
Longford
Health & Safety Specialist
Dublin
Director of Regulatory Affairs
Galway
Principal R&D Engineer
Galway
Quality Assurance Senior Specialist
Louth
MS&T Bioprocess Engineer
Meath
Quality Manager
Dublin
Senior Quality Engineer
Dublin
Quality Systems Manager
Dublin
R&D Engineer
Galway
Electronic Engineering
Dublin
Senior Quality Control Associate
Dublin South
Technical Marketing Manager
Wexford
Learning Systems Lead
Limerick
Senior Operations Engineer
Galway
Advanced Technologies R&D Manager
Clare
Product Development Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Responsible Person (RP)
Republic of Ireland
R&D Engineer
Galway
Sr R&D Manager
Galway
Purchasing & Planning Manager
Wexford
Clinical Research Associate
Cork
Senior Electronics Engineer
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Dublin
Sr R&D Manager
Galway
R&D Manager
Athlone
Senior Design Engineer
Dublin
Clinical Research Manager
Cork
Senior Maintenance Technician
Roscommon
Documentation Specialist
Louth
QC Bioanalytical Sciences - Senior Assoc
Dublin
Senior Regulatory Affairs Specialist
Athlone
Engineering Support Specialist
Louth
Process Engineer
Carlow
Senior R&D Engineer
Galway
R&D Director
Galway
Senior QC Associate
Dublin
Quality Engineer
Galway
Senior Maintenance Technician
Kilkenny
R&D Technician
Galway
Principal Quality Engineer
Galway
R&D Manager
Connaught
Regulatory Affairs Maanger
Galway
Senior Manufacting Engineer
Republic of Ireland
Product Development Engineer II
Athlone
Manufacturing Technician
Clare
Embedded Software Engineer
Dublin
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]