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
GCP Inspector
Dublin
R&D Engineer
Limerick City
Project Manager
Limerick
CQV Lead
Tipperary
Project Engineer
Limerick
Senior R&D Clinical Engineer
Republic of Ireland
Head of R&D
Galway
R&D Engineer
Galway
Senior R&D Engineer
Limerick City
R&D Engineer
Galway
QC Leader
Cork
Project Engineer
Tipperary
CSV Engineer
Limerick
Project Manager
Limerick
Production Team Lead
Dublin South
VP Clinical Development
Republic of Ireland
C&Q Engineer
Dublin
Controls Engineer
Dublin South
R&D Manager
Galway
Process Engineer
Limerick
R&D Engineer
Dublin
Project Engineer
Limerick
Quality Engineer
Limerick
Engineering Technician
Dublin South
Medical Device Director
Republic of Ireland
Project Engineer
Limerick
CAD Technician
Republic of Ireland
Project Engineer
Limerick
Project Engineer
Republic of Ireland
Quality Engineer
Limerick
Senior CSV Specialist- Hybrid
Republic of Ireland
R&D Manager
Galway
Regulatory Affairs Specialist
Republic of Ireland
Quality Specialist
Tipperary
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 Mechanical Engineer


Reference:JCAO1505 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Senior Mechanical Engineer

Our client a high potential medical device start up currently seeking a Senior Mechanical Engineer to join their team. The Senior Mechanical Engineer will work as part of the R&D team and will be responsible for development of mechanical components of a new medical device across all stages of product life-cycle.


Role/Responsibilities:

  • Lead the design and development process of the mechanical components for a novel medical device, in compliance to internal procedures including EU and FDA requirements from design phase up through to production
  • Support / coordinate supplier selection activities.
  • Developing and delivering project plans to performance, time and cost targets
  • Component/assembly design and preparation of associated drawings and specifications.
  • Lead the development of design and risk management documentation, including Market requirements, Design Specifications, Design Verification and Validation protocols and reports.
  • Conduct design reviews and identify potential design risks and develop appropriate risk mitigation plans.
  • Support preparation of compliance package for product evaluation / certification
  • Support preparation of demos for user studies, company presentations, etc.
  • Support clinical studies involving the use of the developed products
  • Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation
  • Ensure full traceability of Design Development and control of changes.
  • Ensure full and effective transfer of system after Design Freeze to manufacturing areas ensuring that the product and processes are developed to allow product/process verification/validation to begin
  • Train, develop and lead R&D engineers and other technical staff. Assign tasks and provide support and assistance to the development team
  • Provide assistance and support to other departments including Manufacturing, Quality and Regulatory as required
  • Management of budget relating to development of mechanical components
  • Agreement of budget relating to human resources needed for mechanical development
Skills/Experience:

  • Minimum Bachelor’s Degree in Mechanical / Medical / BioMedical Engineering
  • 5+ years previous experience in a Medical Devices environment with extensive knowledge of medical device product development
  • Familiarity with medical device regulations and standards (e.g. ISO 13485, IEC 60601, ISO 14971, etc.)
  • Experience with biocompatibility requirements and standards (e.g. ISO 10993-1)
  • Experience with devices that incorporate fabric / textiles
  • Highly proficient in SolidWorks or similar CAD tools
  • Experience with injection mould design and manufacturing.
  • Experience with volume manufacturing
  • Experience with DFM, DFA, DFT, etc.
  • Analytical approach to problem solving and good attention to detail.

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