Position : Validation Lead
Location: San Jose, CA (Onsite)
Long term contract role
Experience: 8+ years
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Eng. / M.S. Mech. Eng.
Job duties:
- Process and equipment qualification (IQ/OQ/PQ).
- Development of test methods for Design V&V, Process Validation, and Production
- Validation of test methods
- Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
- Authoring/releasing of new test methods and editing/redlining of old test methods
- Experience working in a regulated and/or medical device environment
- To define equipment requirements
- To draft equipment specifications
- To work on change management and releasing engineering change orders
- To design process validations and identify critical process parameters related to equipment Working
The experience I am looking for is as follows:
- 6 years of relevant experience in medical device manufacturing.
- Clean room environment experience
- Experience with Test Method Validation and/or Measurement System Analysis is preferred.
- Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
- Strong organizational skills, detail oriented.
- Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint.
- Experience with 3D CAD Software SolidWorks
- Experience working with Engineering change management software & releasing engineering change orders.
