Mechanical Engineer

4 days ago

Dublin, Dublin City, Ireland Guerbet Full time

Direct message the job poster from Guerbet

WHAT WE ARE LOOKING FOR

The Mechanical Engineer is responsible for the design and development of mechanical components & assemblies, and reliability analysis on materials developed for medical devices. The individual will have responsibility for full mechanical design life cycle engineering and post development support for new and existing products.

YOUR ROLE:
  • Perform mechanical design of components and assemblies for medical devices to include material selection, reliability testing, and other related duties.
  • Provide technical support for product changes and new product manufacturing requirements. Develop and implement project plans from concept through feasibility, development, qualification and launch.
  • Manage project plans to meet established schedule and cost targets.
  • Prepare / approve mechanical development documentation, including product requirements, design specifications, and verification and validation protocols
  • Prepare design drawings and layouts for product and component design changes.
  • Responsible to ensure that all product development and design changes conform to the requirements of the Cincinnati Design Control procedures.
  • Conduct / supervise verification and validation testing, and document testing results.
  • Review operations engineering procedures and routings for the production. E.g. process qualification protocol's and process procedures. Assist with operations training on manufacturing equipment and product.
  • Evaluate and implement improvements to product designs and manufacturing processes.
  • Develop, review and approve engineering change orders, considering improvements to quality, cost, customer requirements.
  • Develop, document and lead product validations for product changes and tooling.
  • Analyze, implement, and document design modifications required for improving product reliability.
  • Develop estimates for capital requirements to support products and prepare CER's as necessary.
  • Participate in regulatory audits, FDA, ISO, UL, ETL etc. and resolve findings.
  • Perform other duties that might be required as directed by the department management.
YOUR BACKGROUND:
  • Minimum Bachelors degree in Mechanical Engineering
  • Experience with computer aided design software i.e. Solidworks. (AutoCAD, Creo a plus)
  • Ability to work with CAD data management software i.e. Solidworks PDM
  • Experience with reliability testing methods and principles.
  • The ability to work within the design control processes based upon the understanding of the ISO13485, FDA 21 CFR 820 "Design Control Guidance for Medical Device Manufacturers" and other relevant medical device ISO standards.
  • Understanding and knowledge in the application of root cause analysis and structured problem solving.
  • Ability to identify, analyze and implement improvements independently and to propose changes to existing methods, procedures, processes and/or products.
  • Ability to effectively manage multiple open projects simultaneously. Use of project management skills throughout the project concept, feasibility, development, qualification and launch.
  • Experience and proficient use with Microsoft Office products Word, Excel, and Power Point.
  • Strong written and verbal communication skills.
  • Experience in project management and the use of Microsoft Project a plus.
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Engineering and Project Management
Industries
  • Pharmaceutical Manufacturing and Food and Beverage Manufacturing

Dublin, County Dublin, Ireland

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