Cleaning and Disinfection Verification Engineer

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 

Thank you,
Sachin Patil,
510-402-1063
sachin@apninc.com

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