Title: Cleaning and Disinfection Verification Engineer
Location: Monroeville, PA
Duration: 6 Months
Cleaning and Disinfection Verification Engineer
Description – 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 duties include, but are not limited to:
• 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 Documents preferred:
• FDA Guidance for Industry and FDA Staff, March 17, 2015 – Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
• CDC HICPAC Guideline, 2008 – Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
• AAMI TIR12:2010 – Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, A Guide for Device Manufacturers
• AAMI TIR30:2011 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
• ISO 10993-1:2009 – Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.
• ISO 10993-5:2009 – Biological Evaluation of Medical Devices, Part 5: Test for in vitro cytotoxicity.
• ISO 10993-12:2012 – Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials.
• ISO 14698-1:2003 – Cleanrooms and Associated Controlled Environments, Part 1: Bio contamination Control – General Principles and Methods
• ISO 15883-1:2014 – Washer-disinfectors, General Requirements, terms and definitions and tests.
• Spectaris Guideline