Senior Design Assurance Engineer Role Galway
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Role: Senior Design Assurance Engineer
Industry: Medical Devices
Location: GalwayA key client of ours have just released a new role on their team for an experienced Design Assurance Engineer. The ideal candidate will have 5+ years' experience in a medical device manufacturing environment with direct experience in a design assurance role.The successful candidate will work closely with research and development to establish design specifications and product requirements along with other design related duties to include:
- Lead key elements of the Design Review process in compliance to internal procedures including EU and FDA requirements.
- Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC, MDR and FDA requirements.
- Lead key elements of the risk management process and preparation of risk management files including Hazard Analysis documents, Use FMEA and Design FMEA.
- In conjunction with the R&D/Operations teams identify product testing required and write design verification and validation plans, protocols and reports including specifically advising on sample sizing; including but not limited to Ethylene Oxide sterilization, Biocompatibility, Aging, Packaging and Transportation testing.
- Liaise with external vendors for product testing.
- Preparation of Standard Checklists for all the applicable harmonized standards.
- Generation and/or review of quality and technical documentation / change requests to support design activities.
- Supports regulatory compliance / submission process.Your experience/qualifications:- Ideally will possess Degree / Post-Grad in engineering, biomedical or science degree.
- 5+ 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 (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
- Previous experience in Ethylene Oxide sterilization, biocompatibility, aging, packaging and & transportation testing is an advantage.
- Strong project management skills and attention to detail combined with proven consistent execution within quality, time and cost targets.
- Proven ability to work well as part of a team and on own initiative. To find out more about Real please visit www.realstaffing.comReal 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