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
Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
R&D Engineer
Galway
Project Engineer
Republic of Ireland
R&D Engineer
Dublin
R&D Director
Galway
Medical Device Director
Republic of Ireland
Project Engineer
Tipperary
Senior R&D Clinical Engineer
Republic of Ireland
Project Manager
Limerick
R&D Manager
Galway
CQV Lead
Tipperary
CAD Technician
Republic of Ireland
R&D Director
Galway
R&D Engineer
Galway
R&D Manager
Galway
R&D Manager
Galway
QC Analyst
Cork
Project Engineer
Limerick
Project Engineer
Limerick
Quality Engineer
Midlands
Quality Specialist
Tipperary
Qualified Person
Tipperary
Process Engineer
Limerick
Head of R&D
Galway
Project Manager
Limerick
R&D Director
Galway
R&D Manager
Galway
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

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