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
Senior Design Assurance Engineer
Galway
R&D Manager
Connaught
Mechanical Technician
Carlow
QA Manager
Canada
Change Control SME
Cork
Injection Molding Engineer
North Leinster
Product Development Engineer II
Athlone
Principal Device Engineer
Dublin
Principal Engineer
Dublin
Purchasing & Planning Manager
Wexford
Associate Director - Global Core Labelin
Cork
Product Development Engineer
Galway
Senior Validation Engineer
Carlow
Senior Mechanical Engineer
Dublin
Quality Assurance Specialist (Hybrid)
Dublin
Senior Quality Engineer
Dublin
Senior Validation Engineer
Carlow
Quality Specialist
Dublin
Microbiologist
Cork
Senior Electronic Engineer
Dublin
Quality Engineer
Galway
Electronic Engineer
Dublin
Quality Engineer
Galway
Injection Molding Engineer
North Leinster
Design Assurance Engineer
Galway
Advanced Technologies Manager
Galway
Principal Engineer
Galway
Staff R&D Engineer- Customer Focus
Dublin
Electronic Engineer
Dublin
Compliance Specialist
Carlow
Senior R&D Engineer
Dublin
Production Operator
Carlow
R&D Engineer
Clare
Project Manager - R&D
Galway
Engineering Projects Lead
Carlow
Maintenance Technician
Carlow
R&D Program Manager
Dublin
R&D Engineer
Galway
Technical Transfer Specialist
Cork
Project Manager
Kildare
R&D Senior Program Manager
Galway
Quality Control Technician
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Head of R&D
Galway
Quality Engineer
Wexford
Responsible Person (RP)
Republic of Ireland
Quality Engineer
Galway
Technology Transfer Specialist
Meath
Senior Regulatory Affairs Specialist
Dublin
Senior Equipment Design Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Director of Regulatory Affairs
Galway
Medical Writer
Cork
Process Engineer
Cork
Senior Process Engineer
Dublin
QC Systems Specialist
Dublin
QA Specialist (REMOTE)
Dublin
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
QA Manager
Canada
Principal R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
R&D Engineer
Galway
Utilities Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior Associate Quality Control NPI
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Clinical Research Associate
Cork
R&D Engineer
Dublin
Embedded Software Engineer
Dublin
EHS Systems Specialist
Dublin
R&D Manager
Galway
Mechanical Technician - 2 Cycle
Carlow
QA Engineer
Leitrim
Senior Regulatory Affairs Specialist
Athlone
Validation Specialist - 50/50 remote
Carlow
Scientist (hybrid)
Meath
R&D Engineer
Galway
CTO
Galway
Senior R&D Engineer
Galway
Senior Technical Transfer Engineer - Hyb
Carlow
Sales/Customer Service Administrator
Clonmel
Senior Electronic Engineer - Regulated M
Galway
R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
R&D Engineer
Galway
Project Manager
Kildare
Senior R&D Engineer
Clare
Manufacturing Engineer
Galway
R&D Manager
Dublin
QC Separation Analyst
Cork
Senior Process Development Engineer
Galway
R&D Engineer
Galway
Senior Electronic Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Project Manager Design Assurance
Galway
Quality Specialist
Clare
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Engineer
Galway
Senior QC Associate - Cell Culture
Dublin South
Product Development Engineer II
Athlone
Quality Director
Galway
Senior QC Microbiology (24/7 Shift)
Dublin
R&D Manager
Connaught
Principal/Senior R&D Engineer Cathet
Galway
Quality Specialist
Clare
Electronic Engineer
Dublin
Senior Design Engineer
Dublin
Senior Microbiologist
Dublin
R&D Manager
Galway
MS&T Bioprocess Engineer
Meath
Senior Project Engineer
Cavan
Validation Engineer
Athlone
Design Quality Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Galway
Senior Operations Engineer
Galway
Electrical Project Engineer
Cork
Qualified Person (Hybrid)
Meath
R&D Manager
Galway
Graduate Manufacturing Technician
Kilkenny
Account Manager UK and Ireland
Republic of Ireland
Value Stream Team Leader / Production Su
Wexford
Senior R&D Engineer
Galway
Chief Medical Officer
Dublin
R&D Director
Galway
Maintenance CMMS Engineer
Tipperary
Regulatory Affairs Specialist
Cork
Quality Control Technician
Carlow
Mechanical Design Engineer
Germany
Mechanical Engineer
Tipperary
Senior Maintenance Technician
Roscommon
Senior R&D Engineer
Galway
R&D Manager
Athlone
Manufacturing Engineer
Wexford
Scientific Writer Publications
Cork
Principal Process Equipment Engineer
Dublin South
Senior Equipment Design Engineer
Dublin
Senior QC Associate
Dublin
Senior R&D Engineer
Galway
Project Manager
Louth
Quality Technician
Dublin
Facilities Engineer
Carlow
Product Development Engineer
Dublin
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Program Manager
Dublin
R&D Engineer
Dublin
Senior R&D Engineer
Galway
Biostatistician
Dublin City Centre
Staff Systems Engineer
Limerick
Process Chemist
Limerick
Process Safety Specialist
Tipperary
Engineering Shift Technician
Dublin
Manufacturing Engineer
Cork
Senior R&D Engineer
Clare
Quality Engineer
Athlone
Senior Associate QC
Dublin
Quality Engineer
Athlone
Production Operator
Meath
Lead Maintenance Reliability Engineer
Westmeath
Senior Polymer Development Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Design Assurance Program Manager
Galway
Senior Project Manager - Process Develop
Dublin
R&D Engineer
Galway
Project Engineer
Limerick
Cleaning Validation Specialist
Cork
R&D Engineer
Galway
Production Operator
Dublin
R&D Manager
Galway
Senior Research and Development Engineer
Galway
Regulatory Affairs Associate
Cork
Senior Quality Engineer-Remote
Republic of Ireland
Quality Engineer
Galway
Sourcing Specialist
Tipperary
R&D Project Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Quality Specialist
Tipperary
Senior R&D Manager
Athlone
Product Development Engineer
Galway
Principal Engineer
Dublin
Clinical Research Associate
Cork
CTO
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
R&D Manager
Galway
Notified Body Product Assessor -Active D
Canada
Production Operator
Meath
Principal R&D Engineer
Dublin
Regulatory Associate
Cork
R&D Manager
Athlone
Reliability Engineer
Tipperary
Manufacturing Technician
Clare
Director of Quality Engineering
Limerick
Senior Quality Assurance Systems Special
Dublin
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Change Control Lead
Tipperary
Design Assurance Engineer
Galway
Process Engineer
Carlow
Warehouse Operator
Meath
R&D Engineer
Galway
Cleaning Validation Specialist
Cork
R&D Engineer
Galway
Project Manager Design Assurance
Galway
Product Development Engineer
Dublin
R&D Director
Galway
Senior Design Engineer
Dublin
Quality Engineer
Galway
Principal Process Development Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Technical Life Cycle & Engineering M
Galway
Project Manager - R&D
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Manufacturing Project Engineer
Sligo
R&D Manager
Galway
Procurement Associate
Dublin
R&D Engineer
Galway
Production Operator
Meath
Advanced Technologies R&D Manager
Clare
Senior QC 24/7 Shift
Dublin
Senior R&D Engineer
Galway
Manufacturing Biotech Associate 24/7 Shi
Meath
Project/Process Engineer - Purification
Cork
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior Quality Systems Engineer
Galway
Senior QC Associate
Dublin
Senior R&D Engineer
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
NPI Process Engineer
Carlow
Project Engineer
Cork
Quality and Regulatroy Manager
Galway
Senior Design Assurance Engineer
Athlone
Quality Technician
Dublin
Senior R&D Engineer
Dublin
Quality Assurance Engineer
Longford
R&D Engineer
Galway
R&D Engineer
Galway
Production Manager
Dublin
Electronic Engineer
Dublin
MS&T Associate Director
Dublin
R&D Lifecycle Manager
Connaught
QA Specialist (Hybrid)
Tipperary
Process Simulation Technical Engineer
Carlow
R&D Manager
Galway
Product Development Technician II
Galway
Senior QC Microbiology
Dublin
Manufacturing Technician
Clare
Biomedical Engineer
Dublin
Senior Equipment Engineer
Dublin
Senior Operations Engineer
Galway
Field Service Engineer (Chromatography e
Westmeath
R&D Director
Galway
Material Handler
Carlow
Senior Human Factors Engineer
Dublin
QC Laboratory Technician
Carlow
Senior Quality Engineer
Galway
Process Operations Specialist
Meath
R&D Manager
Connaught
Process Development Engineer
Galway
Quality Operations Manager
Dublin
Senior Technical Transfer Specialist
Cork
Project Manager
Galway
R&D Manager
Galway
R&D Manager
Galway
Technical Specialist - Manufacturing Pro
Cork
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]