Connecting...

Design Assurance Engineer - Hourly Rate Contractor

  • Location:

    Galway

  • Contact email:

    shayes@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +35391 455301

  • Job type:

    Contract

  • Job ref:

    DAENGINEERIIIcontractor

  • Salary:

    Negotiable

  • Published:

    9 days ago

  • Contact email:

    shayes@sigmar.ie

  • Consultant:

    Sarah Hayes

Job description

Design Assurance Engineer Job - Hourly Rate Contractor Role for 12-18 months - Remote Working/Hybrid Option Available! 

The role will focus on review and remediation of our current product offerings to ensure compliance with MDR requirements.

Main Duties/Responsibilities:

  • Work as member of a MDR remediation Team to critically analyse & distil applicable regulatory standards & requirements, assimilate design data and generate/configure technical studies and rationales to fulfil requirements and augment design history files.
  • Review, assessment and where applicable, update Risk Management Documentation to MDR requirements.
  • Review of all process documentation associated with the product remediation in the context of MDR requirements.
  • Provide guidance, direction and supervision to QA Technical Staff where appropriate..

Qualification/Experiences:

  • Bachelor’s Degree in Engineering or equivalent technical qualification.
  • 3-5 years’ experience in a similar role / environment.
  • Experience in the creation of Design Control / Design History File documentation in line with Regulatory Requirements (Preferably MDR).
  • Working Knowledge of the requirements and application of ISO14971:2019.
  • Good working knowledge of regulatory standards and industry practices for Medical Device Manufacture including MDR
  • Proven ability to review complex documents and assimilate information with a high level of detail and accuracy.

You should also have the following abilities/skills/qualities:

  • Ability to work under strict time constraints; meet deadlines in a timely manner with minimal guidance.
  • Team player: Ability to work and communicate effectively as part of QA and cross functional / organisational teams; be flexible with a ‘can do’ attitude.
  • Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
  • Passion for data, analysis, trends, reporting.  Ability to read and interpret documents.  Ability to clearly and informatively write technical documentation, routine reports, correspondence, procedures and work flows. 
  • PC Skills: Standard offices packages and ability to understand and learn customized computer software programs.

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.