Cleaning and Disinfection Verification Engineer

Seeking a Verification and Validation (V&V) Engineer. The selected candidate will work under direct supervision of the V&V Lead to produce clear and concise V&V documents for medical devices. Focus will be assessing and testing cleaning and disinfection (C&D) methods of medical devices for compliance to International Standards and FDA Guidance. Additional responsibilities of testing products at the system level.

Job Description

Work with a team to assess new or changed C&D methods for products
o Identify/generate validation test protocols
o Hold formal technical reviews to determine methods, sample sizes, inoculation points, treatment cycle counts
o Prepare test sample sets for external labs (validation testing) and internal labs (performance testing)
o Monitor test progress to provide status updates during project meetings
o Generate test reports
Manage C&D testing with outside test labs.
o Get quotations
o Write POs
o Prepare samples for testing
o Approve C&D protocols
Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
Develop V&V test plans, test procedures, and test reports.
Review requirements and scrutinize for testability.
Quickly learn to use automated test tools and specialty test equipment.
Execute test procedures both personally and using test technicians.
Log defects and issues found during V&V activities and track to closure.
Perform regression analysis and determine testing associated with design changes.
Provide weekly project status reports.
Prioritize project tasks to complete on schedule while maintaining quality of work.
Work in a team environment; peer review work.
Work on multiple, concurrent projects.
Working knowledge of the following International Standards and Guidance