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/Process Engineer - Purification
Cork
Staff R&D Engineer
Limerick
Process Support Specialist
Carlow
Senior Maintenance Technician
Kilkenny
R&D Manager
Connaught
Maintenance Technician
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Quality Engineer-Remote
Republic of Ireland
Senior R&D Engineer
Galway
CTO
Dublin
Medical Writer
Cork
R&D Manager
Connaught
Territory Sales Specialist (Life Science
Belfast City
Microbiologist
Cork
Biomedical Engineer
Dublin
Senior Quality Engineer
Galway
MS&T Bioprocess Engineer
Meath
Senior QC Microbiology (24/7 Shift)
Dublin
Engineering Projects Lead
Carlow
Senior R&D Engineer
Clare
Senior Microbiologist
Dublin
Senior Engineering Manager
Limerick
Graduate Manufacturing Technician
Kilkenny
Technical Life Cycle & Engineering M
Galway
Senior R&D Engineer
Clare
Senior Quality Engineer
Dublin
Quality Manager
Galway
Senior Recruitment Consultant
Dublin
R&D Manager
Athlone
Project Engineer
Cork
Investigation Lead
Dublin
Project Manager
Louth
Change Control Lead
Tipperary
Staff R&D Engineer- Customer Focus
Dublin
Quality Control Technician
Carlow
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Clare
Senior Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Program Manager
Galway
Project Manager
Kildare
Manufacturing Technician
Clare
Senior R&D Engineer
Dublin
Quality Engineer
Galway
Quality Systems Manager
Dublin
R&D Manager
Galway
Staff Systems Engineer
Limerick
Applications Scientist
Dublin
Project Engineer
Limerick
Material Handler
Carlow
Quality and Regulatroy Manager
Galway
Injection Molding Engineer
North Leinster
EHS Systems Specialist
Dublin
Senior R&D Engineer
Galway
Senior Quality Assurance Systems Special
Dublin
Injection Moulding Engineer
Leitrim
Quality Specialist
Tipperary
Reg Affairs Specialist
Connaught
Regulatory Affairs Specialist
Cork
Program Manager
Galway
R&D Engineer
Galway
QC Separation Analyst
Cork
Senior Technical Transfer Engineer - Hyb
Carlow
Senior R&D Engineer
Galway
Design Assurance Program Manager
Galway
R&D Engineer
Galway
Quality Specialist
Dublin
Process Safety Specialist
Tipperary
Process Engineer
Cork
Product Development Engineer
Dublin
Electronic Design Engineer
Galway
QC Bioanalytical Analyst
Dublin North
Senior Human Factors Engineer
Dublin
R&D Manager
Connaught
Lead Project Engineer
Carlow
Project Engineer
Cork
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Clare
Design Assurance Engineer
Galway
Project Engineer - Senior
Cavan
Quality Engineer
Galway
Quality Specialist
Clare
R&D Engineer
Galway
Senior Regulatory Specialist
Cork
QA Engineer
Leitrim
Qualified Person (Hybrid)
Meath
Senior R&D Engineer
Galway
Microbiology Manager
Dublin
R&D Manager
Galway
Lead Maintenance Reliability Engineer
Westmeath
R&D Manager
Galway
Senior Electronic Engineer - Regulated M
Galway
R&D Engineer
Galway
Clean Utilities Engineer
Carlow
R&D Manager
Athlone
Facilities Engineer
Carlow
R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Senior R&D Engineer
Dublin
MS&T Associate Director
Dublin
R&D Manager
Galway
Sales/Customer Service Administrator
Clonmel
Senior Quality Engineer
Dublin
Project Engineer
Clare
R&D Manager
Galway
Quality Manager - NPI
Dublin
R&D Engineer
Galway
Process Engineer
Galway
Operational Excellence Specialist
Cork
Senior Maintenance Technician
Roscommon
Manufacturing Technician
Clare
Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior Quality Engineer
Leitrim
Maintenance Technician
Kilkenny
Head of R&D
Galway
R&D Engineer
Galway
Design Assurance Engineer
Clare
Production Operator
Meath
Senior Electronic Engineer
Dublin
Reliability Engineer
Tipperary
Principal Process Development Engineer
Galway
CTO
Galway
Clinical Trial Quality Representative
Cork
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
R&D Director
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
CAPA Specialist
Cavan
Electronic Engineer
Dublin
Senior Associate Quality Control
Dublin
Senior Human Factors Engineer
Dublin
Principal Preclinical Scientist
Galway
R&D Engineer
Galway
Quality Engineer
Galway
Principal Scientist/Engineer Medical Dev
Dublin
R&D Engineer
Galway
Maintenance Technician
Carlow
Clinical Research Associate
Cork
Product Development Engineer
Dublin
Senior R&D Engineer
Galway
Product Development Manager
Galway
R&D Manager
Galway
QA Specialist (Hybrid)
Tipperary
Lead Manufacturing Technician
Kilkenny
Project Manager
Kildare
Senior QC Associate
Dublin
Project Manager - R&D
Galway
Cleaning Validation Specialist
Cork
R&D Manager
Dublin
Project Manager Design Assurance
Galway
Senior Regulatroy Affairs Specialsit
Galway
Business Systems Director
Louth
Senior Associate Quality Control
Dublin
NPI Process Engineer
Carlow
R&D Engineer
Galway
Production Operator
Dublin
R&D Manager
Connaught
R&D Director
Galway
Principal R&D Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Product Development Engineer II
Athlone
Senior Design Engineer
Dublin
Electronic Engineer
Dublin
Quality Engineer
Galway
R&D Engineer
Galway
Principal Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Maintenance Reliability Engineer
Tipperary
Sourcing Specialist
Tipperary
Upstream Manufacturing Process Specialis
Cork
Purchasing & Planning Manager
Wexford
Project Engineer
Roscommon
Senior Electrical Engineer
Galway
Electronic Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Manufacturing Technician
Clare
R&D Engineer
Galway
Principal Engineer
Galway
R&D Senior Program Manager
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Principal Engineer
Galway
Product Development Manager
Galway
Manufacturing Engineer
Galway
R&D Manager
Galway
Injection Moulding Engineer
Athlone
Senior Process Development Engineer
Galway
E&I Turnover Engineer
Carlow
Process Chemist
Limerick
Accreditation Manager
Republic of Ireland
Manufacturing Technician
Clare
Director of Regulatory Affairs
Galway
Project Manager - R&D
Galway
Senior Equipment Design Engineer
Dublin
Product Development Technician II
Galway
R&D Manager
Galway
QA Specialist (Shift days)
Dublin
R&D Project Manager
Galway
Principal/Senior R&D Engineer Cathet
Galway
R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Quality Engineer
Galway
Senior Associate QC
Dublin
Production Operator
Dublin
Senior R&D Engineer
Galway
Embedded Software Engineer
Dublin
Manufacturing Engineer
Cork
Senior QC Microbiology
Dublin
Senior R&D Engineer
Dublin
R&D Manager
Galway
Senior R&D Engineer
Galway
Senior Quality Engineer
Galway
Strategic Automation Lead
Waterford
Biostatistician
Dublin City Centre
Senior Polymer Development Engineer
Galway
R&D Technician II
Galway
Quality Engineer
Athlone
Utilities Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Lead Manufacturing Technician
Kilkenny
Product Development Engineer
Galway
Senior R&D Manager
Athlone
Senior Electronics Engineer
Dublin
Design Quality Assurance Engineer
Galway
Senior Manufacturing Manager
Dublin
QA Manager
Canada
Quality Engineer
Galway
Senior Quality Engineer
Leitrim
Technical Life Cycle & Engineering M
Galway
QC Laboratory Technician (shift)
Carlow
R&D Director
Galway
Senior Project Manager - Process Develop
Cork
Shift Technician (Injection Moulding)
Kildare
Senior Tech Transfer Specialist
Meath
Technology Transfer Specialist
Meath
Responsible Person (RP)
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Senior QC Associate - Cell Culture
Dublin South
Senior Associate Quality Control NPI
Dublin
Compliance Specialist
Carlow
R&D Engineer
Galway
Maintenance Technician
Kilkenny
Senior Operations Engineer
Galway
QA Manager
Canada
Account Manager UK and Ireland
Republic of Ireland
QC Systems Specialist
Dublin
R&D Engineer
Dublin
Quality Specialist
Clare
Senior R&D Engineer
Galway
Validation Engineer
Athlone
Quality Engineer
Athlone
Commisioning and Qualification Engineer
Cork
Quality Engineer
Galway
R&D Manager
Galway
Principal Process Development Engineer
Galway
Quality Manager
Dublin
Senior R&D Engineer
Galway
R&D Director
Galway
Senior Project Engineer
Cavan
Electronic Engineer
Dublin
Project Scheduler
Louth
Senior Research and Development Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Laboratory Systems Lead (hybrid)
Meath
R&D Lifecycle Manager
Connaught
Design Assurance Engineer
Galway
Utilities Engineer - Black Utilities
Roscommon
QC Laboratory Technician
Carlow
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]