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
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
CSV Engineer
Limerick
Senior Regulatory Affairs Specialist
Dublin
Senior Medical Director Neuroscience
Cork
Senior Technical Sales Specialist
Kilkenny
Associate Director, Supply Chain
Dublin
Manufacturing Specialist
Dublin South
Process Team Lead
Donegal
QC Leader
Cork
Fluent French and Arabic Customer Excell
Cork
Senior Quality Engineer
Limerick
Clinical Trials Start up Associate Fluen
Cork
Senior R&D Engineer
Galway
Senior Regulatory Affairs
Galway
Design Assurance Engineer
Galway
Snr Facilities Engineer
Dublin South
Quality Assurance Assistant
Cork
Project Engineer
Cork
Environmental Officer - Part-time or Ful
Kerry
R&D Manager
Galway
Project Engineer
Limerick
Facilities Maintenance Technician
Galway
Business Development Manager (Eyecare) -
Dublin
Process Technician
Donegal
Process Lead
Donegal
Qualified Person - Pharmaceutical
Cork
Electrical Design Engineer
Galway
Manufacturing Engineer
Galway
Senior Polymer Development Engineer
Galway
Project Engineer
Limerick
Senior R&D Engineer
Dublin
Senior Clinical Research Associate
Dublin
Senior Medical Writer
Dublin
GCP Inspector
Dublin
Senior R&D Engineer
Limerick City
Engineering Technician (Packaging)
Dublin South
LIMS Templator / LIMS Data Entry
Dublin
EH&S Specialist
Longford
Process Engineer
Galway
Quality Engineer
Wexford
Innovation Grant Project Coordinator
Galway
Project Manager
Kildare
Senior Manager
Dublin
R&D Engineer
Limerick City
Controls Engineer
Dublin South
R&D Test Engineer
Galway
R&D Senior Program Manager
Galway
Manufacturing Quality Engineer
Galway
R&D Engineer
Dublin
Technical Operations Specialist (Process
Cork
R&D Mechanical Technician
Galway
Director, Clinical Development (Oncology
South East
Materials Engineer
Cork
Senior Quality Engineer
Cork
R&D Engineer
Galway
Process Team Lead
Donegal
Snr EH&S Specialist
Longford
Program Manager
Galway
Senior QA Specialist
Dublin
Medical Information Associate Fluent Spa
Cork
MDR/Vigilance Specialist
Galway
Senior Manufacturing Engineer
Cork
CQV/Validation Engineer
Dublin
NPD Manager
Galway
Regulatory Affairs Specialist
Republic of Ireland
Senior R&D Engineer-New Product Deve
Westmeath
Technical Operations Engineer
Cork
Quality Specialist
Tipperary
Maintenance Technician- Nights
Galway
Microbiology Manager
Dublin
Sales Specialist (Pharmaceutical: Multi-
Longford
Quality - Tech Transfer Specialist
Cork
NPD Manager
Galway
R&D Engineer
Galway
Quality Engineer
Limerick
Engineering Technician
Dublin South
Lab Services Team Lead
Dublin
Process Team Lead
Donegal
Engineering Technician
Dublin South
Biomedical Engineer
Dublin
Senior R&D Engineer
Dublin
Senior Quality Engineer
Dublin
Project Manager
Limerick
Process Engineer
Galway
Senior Validation Engineer
Limerick
Development Clinical Research Scientist
Cork
Senior Product Development Engineer
Galway
Design Assurance Engineer
Galway
R&D Director
Galway
Head of R&D
Galway
Warehouse Manager
Dublin
Global Head of R&D
Republic of Ireland
TMF Projects Associate - French
Cork
Surgical Territory Account Manager (Spin
Dublin
Global Manager Innovation Quality
Galway
Senior Automation Engineer
Dublin South
R&D Manager
Galway
Product Development Scientist
Galway
Clinical Evaluator
Republic of Ireland
Senior R&D Clinical Engineer
Republic of Ireland
Senior Business Development Manager (Cel
Kilkenny
Lead Chemistry Analyst
Cork
Lead Maintenance Reliability Engineer
Westmeath
Pharmaceutical Project Management - Asso
Cork
QC Team Leader
Cork
Clinical Statistical Analyst
Cork
Design Assurance Engineer
Republic of Ireland
Environmental Health & Safety Lead
Louth
R&D Manager
Galway
Process Engineer
Galway
Senior Design Quality Engineer
Galway
Medical Information Associate
Cork
Operations Manager
Donegal
Sales/Customer Service Administrator
Clonmel
Territory Account Manager (Gynaecology)
Dublin
Senior Product/Process Development Engin
Dublin
Process Engineer
Limerick
R&D Engineer
Galway
Senior Project Manager - Manufacturing
Cork
Equipment Mechanical Design Engineer
Galway
Quality Systems Specialist
Limerick
Project Engineer
Limerick
Senior Program Manager - Sustainability
Cork
Senior CSV Specialist- Hybrid
Republic of Ireland
Project Engineer
Limerick
EMEA Global distribution Operations
Dublin
Design Quality Engineer
Galway
Project Engineer - Innovation Centre
Cork
Senior Manager Clinical Central Services
Cork
Controls Technician Nights
Galway
Senior Quality Engineer
Galway
Senior Associate External Planning and D
Dublin
Snr Supplier Quality Engineer
Galway
Senior Quality Assurance Specialist
Dublin
Clinical Trials Project Manager
Cork
Controls Engineer
Dublin South
Senior Project Engineer - Equipment Proj
Limerick
Regulatory CMC Associate
Cork
Process Engineer
Galway
Publications Scientific Communications A
Cork
Senior Reguatory Specialist
Galway City
Qualified Person
Cork
C&Q Engineer
Dublin
Clinical Research Scientist - Medical Af
Cork
Senior R&D Engineer
Dublin
Manufacturing Engineer
Wexford
NPD Manager
Galway
Contract Management Associate
Cork
Senior Manufacturing Quality Engineer
Dublin
Senior Engineering Manager
Limerick
R&D Manager
Galway
Quality Engineer
Limerick
Project Engineer
Limerick
Quality Assurance Administrator
Cork
Engineering Technician
Dublin South
Senior Process Development Engineer
Galway
Senior Manufacturing Engineer -Coatings
Limerick
Controls Engineer
Dublin South
Process Validation Engineer
Cork
Senior Manufacturing Engineer
Galway
Senior Quality Engineer
Dublin
Technical Operations Specialist - CPV &a
Cork
Production Team Lead
Dublin South
Maintenance Technician- Nights
Galway
Senior Project Engineer
Cork
Clinical Central Services and Innovatio
Cork
Senior Process Development Engineer
Galway
QA Contractor
Dublin City Centre
Senior Validation Engineer
Cork
Development Clinical Research Physician
Cork
Maintenance Engineer/ Technician
Dublin South
Quality Assurance and Regulatory Affairs
Sligo
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

Senior Product Development Engineer


Reference:JCAO1122 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Senior Research and Development Engineer

Our client an exciting and growing medical device company currently seeks a Senior Product Development Engineer to join their team. Reporting to Product Development Manager, the product development manager will provide key support to the Product Development function in developing products, processes, materials requirements and equipment in order to achieve design brief. Ensure the company’s design control responsibilities are fulfilled, specifically development and design verification phases and related sustaining engineering activities


Role/Responsibilities

  • Lead the Design and Development process for both new and transfer products in compliance to internal procedures including EU and FDA requirements from Development phase up to Transfer to Production.
  • Gathering clinical/user needs and translation into technical specifications.
  • Component/assembly design and preparation of associated drawings and specifications.
  • Assist Research & Process Technologies function on developing early prototypes.
  • Transform early feasibility design into design freeze stage by building, testing and refining all design aspect.
  • Test method development; identification and procurement of equipment for inspection and test, test method validation and training.
  • Identify product testing required; create design verification and validation plans, protocols and reports including specifically advising on sample sizing; Stability and Transportation testing
  • Generation, analysis and interpretation of test data.
  • Aid with the preparation of risk management files including Use and Design FMEAs as required in accordance with company procedures and EN ISO 14971.
  • Assist Design Assurance on Design History files.
  • Generation and/or review of technical documentation / change requests related to design activities.
  • Developing and delivering project plans to performance, time and cost targets.
  • Liaising with external resources to achieve project goals.
  • Application of Engineering methodologies in device design and test method development
  • Structured Problem Solving and Decision Making
  • Translating clinical/user needs into technical specifications.
  • Design Verification including product specific functional tests, stability and transportation testing.
  • Excellent working knowledge of statistical methods commonly used in product/process design and validation.
  • Application of standard regulatory requirements (CE & FDA)
  • Risk Management; Design and Use FMEA
  • Project management through all phases of the Design & Development processes
  • Excellent presentation, verbal and written communication skills.
  • Change control management; design, process and system.
  • Quality of Work; maintains high standards despite pressing deadlines.


Skills/Experience

  • Mechanical or Biomedical engineering degree or equivalent.
  • Minimum 5 years’ experience in medical device design/development or similar role in a medical device company.
  • Strong technical aptitude with a good understanding of fundamental engineering principals and materials.
  • Broad knowledge of materials and processes used in medical devices.
  • Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
  • Working knowledge of the Medical Device Directive (93/42/EEC) and FDA requirements including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.


For further information please contact James Cassidy [email protected] or call in confidence 086 0204322