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 support and guidance to NPD teams for process validations required during the NPD process.
These validations may be conducted at NuVasive’s internal manufacturing 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 a 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.
- Author and execute protocols and reports for IQs, OQs, PQs and PPQs. Validations will include legacy, new and changed products, processes, systems and equipment
- Conduct gap analyses and remediation on Design History Files to ensure compliance with external regulations and internal procedures
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of manufacturing problems
- Lead periodic performance/data review of critical equipment and processes
- Lead cleaning validation and annual monitoring projects
- Conduct audits of validation and performance qualificationprocesses to ensure compliance with internal and regulatory requirements
- Conduct Quality planning to establish and implement timely validation plans, risk analysis, control plans, and inspection plans for in-process and final inspection
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
- 8+ years of related experience with a Bachelor’s degree; or equivalent experience
- Familiarity with processes in a CNC Manufacturing environment
- Ability to read and interpret mechanical drawings, including GD&T
- DOE and Applied statistical knowledge and experience
- American Society for Quality Certified Quality Engineer (CQE) desirable
- Proficiency in Minitab
- DOE experience
- Six Sigma Black Belt