Location: Balybrit, Galway
Benefits: Career progression, an excellent salary, 22days annual leave, PRSA and stock options.
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.
- 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.
- 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.
Looking forward to hearing from you
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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