MINIMUM REQUIREMENTS:
Must have a bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, Biomedical Engineering, Engineering Mechanics or a related field plus minimum 2 years of experience in the job offered or related role in the biomedical engineering industry.
Of the required experience, must have a minimum of 2 years of experience in each of the following:
· Computer Aided Design (CAD), such as SolidWorks.
· Project Management of cross functional team activities in a defined scope by developing activity schedules, identifying risks/mitigations, and providing status updates to management.
· Technical Writing such as presenting complex engineering and clinical data for peer review and/or audit by 3rd parties.
· ISO 13485:2016, ISO 14971:2019, IEC/ISO 62366:2015, and ISO 10993 series.
· FDA 21 CFR 820, EU MDD Directive 93/42/EEC, and EU MDR Regulation 2017/745.
· External audit support, such as interfacing with regulatory bodies and preparing technical submission responses.
· Risk Analysis.
· FDA Design Control.
· MS Word, MS Excel, and MS PowerPoint.
· Minitab or other statistical software.
· ERP systems such as SAP.
· PLM systems such as Agile.
Up to 10% travel required (domestic and international).
How to apply: Apply online at https://www.smith-nephew.com/careers/ click on vacancies and search Quality Engineer 2 (REQ: R71020).
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