Senior Design Assurance Engineer

Real Staffing

  • Galway
  • Permanent
  • Full-time
  • 30 days ago
Job title: Senior Design Assurance Engineer

Location: Balybrit, Galway

Benefits: Career progression, an excellent salary, 22days annual leave, PRSA and stock options.

Company:

My client is a privately held clinical stage company who are dedicated to developing a minimally invasive transcatheter solution. You will get the opportunity to work with experts in the structural heart field leading a team of Engineers.

Responsibilities:
  • Lead key elements of the Design Review process in compliance to internal procedures including EU and FDA requirements
  • Work with R&D to establish design specifications and product requirements.
  • Lead key elements of the risk management process and preparation of risk management
  • In conjunction with the R&D/Operations teams identify product testing required and write design verification and validation plans, protocols and reports
  • Generation and/or review of quality and technical documentation / change requests to support design activities.
  • Support various QA/RA activities including quality management, system reviews, internal & vendor audits
  • Supports regulatory compliance / submission process.
Requirements:
  • Possess Degree / Post-Grad in engineering, biomedical or science degree.
  • 4+ years' experience in a medical device manufacturing environment with direct experience in a design assurance role.
  • Working knowledge of the Medical Device Directive (93/42/EEC)/Medical Device Regulation 2017/745 and FDA requirements including Quality System Regulation
  • Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971
  • Experience in mentoring/guiding team members.
If you are interested in applying and hearing more about this new opportunity forward a copy of your up to date CV or contact the details mentioned.

Looking forward to hearing from you

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Real Staffing

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