HI ,

I hope you are doing good,

Please check the below job description and let me know your interest.







*Job Title: System Engineer / Computer System Validation / Embedded Test
Engineer Location: Warsaw, IN Duration: 6+ Months Job Description: *

•         Compliance Analysis, Compliance Plan document, User Requirements
document, Functional Requirements document, Risk Assessment document

·         System Test Protocol/ Scripts, User Acceptance Test Protocols/
Scripts, System Test Reports, User Acceptance Test Reports, Compliance
Report

•         Hands on experience in preparing test cases using Black box
testing techniques

·         Able to create Test Cases from the Functional Specifications /
Software Requirement Specification document.

·         Able to test the Functionality as per the Test plan and
respective Test Cases.

·         Good communication skills /  He has to work  independently with
customer

·         Hands on experience in leading, mentoring, assigning the work to
team members and has worked in effort estimation.

·         Exposure to ISO13485, 14971

·         Knowledge on FDA regulations and guidelines.

•         Team Interaction with Cross function stakeholders

•         Technical reviews of Verification work products

•         Coordination between team members

•         Obtain clarifications and feedback from Customer

•         Organize reviews and team meetings.

•         Release deliverables and project administrative activities



*Skill Matrix:*

*Technical / Soft Skills*

*Expertise Level (Expert / Good / Knowledge)*


* Years Of Experience*

Embedded testing manual





Test Design Techniques





CSV Process





Compliance Analysis and Risk Assessment





Medical devices Testing





STLC



Project Management-Budget/Cross Functional cummication





CNC/DNC





 ISO 13485





 ISO14971





 FDA





GMP











Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

E:  saikiran.nandr...@w3global.com

A:  1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034

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