The Senior Validation Engineer will lead efforts to validate products and processes in support of the new Medical Device Regulation (MDR) for CE marked medical devices. Work will be focused on legacy product lines, but will also participate in the New Product Development (NPD) process by providing supportand guidance to NPD teams for process validations required during the NPD process. These validations may be conducted at NuVasive’s internalmanufacturing facility in Ohio, at any of our Contract Manufacturer facilities, or in NuVasive’s test labs in San Diego. Responsibilities will include authoring and approving validation protocols and reports, creating statistical rationale for sample sizes and analysis of test data via statistical methods. The role may also include assisting in the management of the Validation Master Plan for the Global Prototyping and Manufacturing Engineering Team.
Manage CAPA and Process improvement projects driving root cause investigation and corrective action implementation.
Train, guide, influence and mentor other Engineers in Validations and Root Cause Analyses
Support of process development, process monitoring and production transfer activities.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, 21 CFR 820, and the European Medical Device Regulation.
Duties to be performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR Part 820, ISO 13485, and the European Medical Device Regulation.