Lead Validation Engineer

Responsibilities:

1. 6 years relevant experience in medical device manufacturing.
2. Clean room environment experience.
3. Experience with Test Method Validation and/or Measurement System Analysis is preferred.
4. Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
5. Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
6. Strong organizational skills, detail oriented.
7. Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Marketing, Quality, etc.)
8. Ability to work to a deadline and to handle multiple tasks simultaneously.
9. Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint.
10. Experience with 3D CAD Software SolidWorks.
11. Experience working with Engineering change management software & releasing engineering change orders.

Requirements:

1. Process and equipment qualification (IQ/OQ/PQ).
2. Development of test methods for Design V&V, Process Validation, and Production.
3. Validation of test methods.
4. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work.
5. Authoring/releasing of new test methods and editing/redlining of old test methods.
6. Experience working in a regulated and/or medical device environment.
7. To define equipment requirements.
8. To draft equipment specifications.
9. To work on change management and releasing engineering change orders.
10. To design process validations and identify critical process parameters related to equipment working.