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
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Hot Science Jobs
Scientist (hybrid)
Meath
Electronic Engineer
Dublin
Senior Design Assurance Engineer
Galway
Injection Molding Engineer
North Leinster
Quality Specialist
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Injection Molding Engineer
North Leinster
Senior Quality Engineer
Leitrim
Manufacturing Engineer
Cork
Accreditation Manager
Republic of Ireland
R&D Director
Galway
R&D Director
Galway
Product Development Engineer
Galway
Quality Engineer
Galway
Production Operator
Carlow
Quality Engineer
Galway
Chief Medical Officer
Dublin
Quality Manager - NPI
Dublin
Maintenance Technician
Carlow
QA Manager
Canada
Principal Process Development Engineer
Galway
QA Specialist (REMOTE)
Dublin
R&D Manager
Dublin
R&D Engineer
Galway
Supply Associate QC - Metrics & Anal
Dublin
Senior Quality Engineer
Galway
Senior R&D Engineer
Clare
Senior R&D Engineer
Galway
MS&T Bioprocess Engineer
Meath
Program Manager
Galway
Design Quality Assurance Engineer
Galway
Purchasing & Planning Manager
Wexford
Quality Specialist
Clare
Quality Engineer
Galway
R&D Engineer
Galway
Project Manager Design Assurance
Galway
Senior Equipment Design Engineer
Dublin
Senior Project Manager - Process Develop
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Manager
Athlone
CTO
Galway
Senior R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Mechanical Technician - 2 Cycle
Carlow
MS&T Scientist Specialist
Meath
R&D Engineer
Galway
QA Engineer
Leitrim
Product Development Engineer
Dublin
Senior Quality Control Associate
Dublin South
Principal Preclinical Scientist
Galway
Senior QC 24/7 Shift
Dublin
Quality Manager
Dublin
R&D Technician II
Galway
R&D Engineer
Galway
Graduate Manufacturing Technician
Kilkenny
Cleaning Validation Specialist
Cork
Shift Technician (Injection Moulding)
Kildare
R&D Manager
Connaught
Senior Maintenance Technician
Kilkenny
Principal Heart Valves Engineer
Galway
R&D Manager
Galway
Clinical Research Associate
Cork
Senior Research and Development Engineer
Galway
Manufacturing Engineer
Cork
Associate QA Specialist (Shift)
Carlow
R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Engineer
Clare
Design Assurance Engineer
Galway
Microbiologist
Cork
Strategic Automation Lead
Waterford
Program Manager
Galway
QA Manager
Canada
Project Scheduler
Louth
R&D Engineer
Galway
Cleaning Validation Specialist
Cork
R&D Engineer
Galway
Investigation Lead
Dublin
Quality Director
Galway
Quality Engineer
Wexford
Senior Regulatory Affairs
Galway
Compliance Specialist
Carlow
Quality and Regulatroy Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Notified Body Product Assessor -Active D
Canada
Senior Mechanical Engineer
Dublin
Production Operator
Meath
Principal R&D Engineer
Galway
Product Development Engineer
Dublin
Product Development Engineer
Dublin
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior Regulatory Affairs Specialist
Westmeath
Clinical Trial Quality Representative
Cork
Quality Engineer
Athlone
Associate Director Computer Systems Qual
Limerick
Maintenance Technician
Kilkenny
Medical Writer
Cork
R&D Manager
Galway
Operations Engineer
Galway
Quality Engineer
Galway
Senior Manufacturing Engineer
Galway
R&D Manager
Galway
Project Engineer
Cork
Validation Engineer
Athlone
Head of R&D
Galway
MS&T Associate Director
Dublin
Design Assurance Engineer
Galway
Project Manager
Kildare
R&D Engineer
Galway
R&D Project Manager
Galway
Quality Technician
Dublin
QA Specialist (Hybrid)
Tipperary
Senior Process Engineer
Dublin
Project Manager
Louth
Principal Engineer
Galway
Principal R&D Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Senior Regulatory Affairs Specialist
Athlone
CTO
Dublin
Senior R&D Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Advanced Technologies R&D Manager
Clare
Sr. Associate - Quality for Computer Sys
Cork
Quality Specialist
Dublin
Project Engineer
Cork
Engineering Projects Lead
Carlow
Senior Human Factors Engineer
Dublin
R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Maintenance Reliability Engineer
Cork
Senior Associate Quality Control NPI
Dublin
R&D Engineer
Dublin
Quality Specialist
Clare
Senior Procurement Associate
Limerick
QC Laboratory Technician
Carlow
Senior Quality Engineer
Dublin
Product Development Engineer
Galway
R&D Manager
Galway
R&D Manager
Connaught
Senior Quality Engineer
Dublin
Project Engineer
Limerick
Principal/Senior R&D Engineer Cathet
Galway
Mechanical Design Engineer
Germany
Production Operator
Meath
R&D Engineer
Galway
Technical Transfer Specialist
Cork
Manufacturing Engineer
Galway
R&D Engineer
Galway
R&D Manager
Athlone
R&D Manager
Athlone
R&D Manager
Galway
Project Manager - R&D
Galway
Senior Quality Engineer
Dublin
MS&T Associate Director
Dublin
Maintenance Reliability Engineer
Tipperary
Associate Director - Global Core Labelin
Cork
Product Development Manager
Galway
Material Handler
Carlow
Senior Equipment Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer
Galway
QC Laboratory Technician (shift)
Carlow
Electronic Engineer
Dublin
Senior Electronics Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Connaught
E&I Turnover Engineer
Carlow
R&D Engineer
Galway
Biostatistician
Dublin City Centre
Senior R&D Engineer
Galway
R&D Manager
Galway
Maintenance Technician
Kilkenny
Manufacturing Project Engineer
Mayo
Quality Control NPI Senior Associate
Dublin South
Product Development Technician II
Galway
Senior R&D Engineer
Galway
Senior Polymer Development Engineer
Galway
Utilities Engineer
Dublin
Change Control SME
Cork
Senior Manufacting Engineer
Republic of Ireland
R&D Manager
Galway
Process Simulation Technical Engineer
Carlow
Quality Systems Manager
Dublin
Account Manager UK and Ireland
Republic of Ireland
Senior Operations Engineer
Galway
Cleaning Validation Engineer
Carlow
Staff R&D Engineer- Customer Focus
Dublin
R&D Manager
Galway
Process Operations Specialist
Meath
R&D Engineer
Galway
Senior Operations Engineer
Galway
Business Development Manager (GPs) - Lei
Dublin
Maintenance Technician
Kilkenny
Senior R&D Engineer
Galway
Applications Scientist
Dublin
Maintenance CMMS Engineer
Tipperary
Regulatory Affairs Associate
Cork
Production Operator
Meath
Electronic Engineer
Dublin
Senior Technical Transfer Specialist
Cork
Project Manager
Kildare
R&D Engineer
Galway
R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Manager/Director
Dublin
Production Operator
Dublin
R&D Manager
Connaught
Engineering Business Manager
Dublin
Lead Project Engineer
Carlow
Quality Technician
Dublin
Product Development Engineer II
Athlone
Senior Equipment Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Dublin
Senior Electronic Design Engineer
Dublin
EHS Systems Specialist
Dublin
Senior Process Development Engineer
Galway
Upstream Manufacturing Process Specialis
Cork
Cleaning Validation Specialist
Cork
Senior R&D Engineer
Dublin
Maintenance Technician
Carlow
Senior Recruitment Consultant
Republic of Ireland
Principal Device Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Process Engineer
Cork
Quality Assurance Specialist (Hybrid)
Dublin
Product Development Technician II
Galway
R&D Director
Galway
Electronic Engineer
Dublin
Production Operator
Meath
Project Manager - R&D
Galway
Process Engineer
Galway
Embedded Software Engineer
Dublin
Process Development Engineer
Galway
Quality Assurance Engineer
Longford
Pharmacovigilance Manager (Remote)
Republic of Ireland
Qualified Person (Hybrid)
Meath
Product Development Engineer II
Athlone
R&D Engineer
Galway
Production Operator
Carlow
Technical Administrator
Tipperary
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
R&D Program Manager
Dublin
Project Manager - R&D
Galway
Senior R&D Project Manager
Galway
Validation Specialist - 50/50 remote
Carlow
Senior Quality Engineer
Dublin
Clean Utilities Engineer
Carlow
Process Chemist
Limerick
Project Manager Design Assurance
Galway
Project/Process Engineer - Purification
Cork
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
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

Principal Scientist/Engineer Medical Device Development


Reference:SCA014442 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, Design Engineer, Inhalations Scientist, Principal Engineer, Principal Research Scientist, Principal Scientist, Research and Development Engineer, Research Scientist

Principal Scientist/Engineer Medical Device Development
Our Dublin based client are currently recruiting for a highly skilled Principal Scientist/Engineer to join their Device and Product Performance team on a permanent basis. In this role, you will lead the design, development, and performance evaluation of drug-device combination products, ensuring they meet regulatory and quality standards. Your expertise will drive technical excellence, innovation, and patient-centric solutions.

Responsibilities

  • Provide subject matter expertise to support the development of Combination Products
  • Plan and execute design verification and reliability strategies
  • Be the technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development
  • Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements
  • Develop test methods and specifications to assess device functionality and product performance including evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicable
  • Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification
  • Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans
  • Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability
  • Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system
  • Lead support activities for external and internal audits and inspections as applicable
Requirements
  • Degree in Science/Engineering (Master’s preferred)
  • 7+ years’ experience in pharmaceutical and/or medical device development
  • Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage
  • Experience in the development and validation of analytical methods
  • Experienced in application of statistical techniques for data analysis
  • Experience of writing and supporting regulatory submissions
  • Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role
  • Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders
  • Some travel will be required as part of this role

For more information, please contact Sinéad Cullen on +353879500821 or [email protected]