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
Engineering Support Specialist
Louth
Advanced Technologies Manager
Galway
Regulatory Affairs Specialist
Cork
Principal R&D Engineer
Dublin
Manufacturing Technician
Clare
Senior Associate Quality Control (Shift)
Dublin
Documentation Specialist
Louth
Site Microbiologist
Republic of Ireland
Senior Equipment Engineer
Dublin
Quality Manager - NPI
Dublin
Product Development Manager
Galway
Product Development Technician II
Galway
Regulatory Associate
Cork
Electrical Condition Monitoring Technici
Limerick
Senior Maintenance Technician
Kilkenny
Project Manager
Kildare
Senior Equipment Design Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
MS&T Bioprocess Engineer
Meath
R&D Director
Galway
Injection Moulding Engineer
Leitrim
Quality Specialist
Clare
R&D Director
Galway
Quality Technical Services Manager - 12
Dublin
Project Engineer
Limerick
Production Operator
Carlow
Quality Manager
Dublin
Senior Research and Development Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Senior Regulatory Affairs
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Manufacturing Project Engineer
Mayo
Health & Safety Specialist
Dublin
Senior Regulatory Affairs Specialist
Clare
Biomedical Engineer
Dublin
Project Engineer - Senior
Cavan
Staff R&D Engineer
Limerick
Principal Reliability Engineer
Galway
R&D Manager
Galway
Principal Engineer
Dublin
Senior Electronic Engineer
Dublin
Principal R&D Engineer
Galway
R&D Manager
Dublin
Senior Equipment Design Engineer
Dublin
Design Assurance Program Manager
Galway
CTO
Galway
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
R&D Director
Galway
Senior Design Assurance Engineer
Galway
Principal R&D Engineer
Galway
Senior Product Development Engineer
Galway
Quality Technician
Dublin
Senior Validation Engineer
Dublin
R&D Engineer
Galway
Senior Validation Engineer
Louth
Senior R&D Engineer
Galway
Documentation Specialist
Louth
QA Manager
Canada
Senior R&D Engineer
Dublin
Design Quality Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
Senior Equipment Design Engineer
Dublin
Principal Research and Development Engin
Galway
Senior Regulatory Affairs Specialist
Athlone
National Sales Manager
Dublin
Principal Software Engineer
Athlone
Senior Design Engineer
Dublin
Project Manager - R&D
Galway
Quality Engineer
Galway
Strategic Automation Lead
Waterford
Manufacturing Project Engineer
Sligo
Senior Recruitment Consultant
Republic of Ireland
Purchasing & Planning Manager
Wexford
Cleaning Validation Specialist
Cork
Warehouse Operator
Meath
Product Specialist (Peripheral Endovascu
Dublin
Microbiology Manager
Dublin
R&D Technician
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior Operations Engineer
Galway
Process Engineer
Galway
R&D Manager
Connaught
Senior R&D Engineer - Sustaining
Galway
Product Development Engineer
Dublin
Purchasing & Planning Manager
Wexford
Electronic Engineer
Dublin
R&D Manager
Athlone
Regulatory Affairs Maanger
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Manager - Medical Devices
Limerick City
R&D Manager
Connaught
R&D Engineer
Galway
Design Assurance Engineer
Clare
Senior Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Clinical Research Associate
Cork
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Product Development Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Product Development Engineer
Dublin
Product Development Engineer
Dublin
Territory Manager (Woundcare)
Cork
R&D Engineer
Galway
Maintenance Manufacturing Technician
Kilkenny
Senior Quality Systems Engineer
Galway
Manufacturing Engineer
Wexford
Project Manager
Kildare
R&D Manager
Galway
Sr R&D Manager
Galway
Product Development Engineer II
Athlone
R&D Manager
Connaught
Senior Regulatroy Affairs Specialsit
Galway
Senior R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Documentation Specialist - Upstream Oper
Dublin
Senior R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Maintenance Reliability Engineer
Cork
Project Engineer
Cork
Senior Operations Engineer
Galway
R&D Engineer
Galway
Quality Manager
Dublin
MS&T Scientist - AKTA systems
Meath
Senior Project Engineer
Cavan
Application Software Engineer
Galway
Quality Engineer
Galway
Documentation Specialist
Louth
Electronic Engineer
Dublin
QA Engineer
Leitrim
R&D Engineer
Dublin
Production Manager
Dublin
Calibration Technician
Republic of Ireland
Product Development Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Reg Affairs Specialist
Connaught
Project Manager - New Product Introducti
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
Sourcing Specialist
Tipperary
R&D Manager
Athlone
CTO
Dublin
Team Leader - Lab Services
Dublin
R&D Director
Galway
Senior Manufacturing Engineer
Galway
R&D Engineer
Dublin
Senior QC Associate
Dublin
Senior Quality Assurance Specialist (Shi
Dublin
Electronic Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Galway
R&D Manager
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Project Engineer
Cavan
R&D Engineer
Galway
Principal Design and Development Enginee
Galway
Senior Quality Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
Principal R&D Engineer
Galway
Quality Assurance Associate
Cork
Mechanical Technician - 2 Cycle
Carlow
R&D Engineer
Clare
Operational Excellence Specialist
Cork
Design Assurance Engineer
Galway
Sr R&D Manager
Galway
Program Manager
Dublin
Manufacturing Engineer
Galway
R&D Manager
Connaught
Electronic Engineering
Dublin
Senior Quality Engineer
Leitrim
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Process Chemist
Limerick
Senior Quality Control Associate
Dublin South
Maintenance CMMS Engineer
Tipperary
Software Design Assurance Engineer
Dublin
Project Engineer
Clare
E&I Turnover Engineer
Carlow
Senior Quality Engineer
Galway
Senior Product Development Engineer
Galway
Quality Specialist
Tipperary
Senior R&D Engineer
Galway
Project Manager - R&D
Galway
Quality Engineer
Galway
Quality Engineer
Athlone
Senior Quality Engineer
Galway
Manufacturing Technician
Clare
R&D Engineer
Galway
Senior Electronics Engineer
Limerick
Change Control SME
Cork
R&D Technician II
Galway
Quality Assurance Senior Specialist
Louth
Senior R&D Engineer - Sustaining
Galway
Senior Quality Engineer
Dublin
Operations Engineer
Galway
Product Development Engineer
Galway
Clinical Research Associate
Cork
Staff Systems Engineer
Limerick
Utilities Engineer
Dublin
Product Development Engineer
Dublin
Principal R&D Engineer
Dublin
R&D Engineer
Galway
Senior Recruitment Consultant
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]