Job Description :
Job description with high-level requirements are listed as below.
1. Responsible for Project management in order to successfully complete the defined scope within agreed time line
2. Refinement and validation of Marketing requirements with cross functional team and customer stake holder
3. Co-ordinate with Onsite and offshore for the project related activities
4. Coordinate with customer internal / external partner facilities to define the Design of experiment to perform the cleaning and sterilization activities for all the defined requirements .
5. Efficacy Validation of FDA approved neutral detergent for the reusable device under scope
6. Coordinate with outside Lab for conducting all the cleaning Efficacy testing and survivability tests in order to conclude the sterilization requirements defined per various country specific requirements
7. knowledge on the International standards as listed below to perform the cleaning and sterilization process validation in order to compliance to various country requirements
(i) AAMI TIR:12 - Designing, Testing, Labelling reusable medical device for reprocessing in healthcare facilities.
(ii) AAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices.
(iii) EN 285 - Steam sterilizers.
(iv) ISO 17665 - Sterilization of healthcare products.
(v) ISO 17664 – Processing of healthcare products.
8. Providing Redline markup on the cleaning and sterilization procedure to the customer to Update respective IFU and DHF.
9. Responsible for all the defined deliverables under project scope