Validation Position

Hi,

          Please find the below requirement and let me know your consultant comfort levels. Please send matching profiles to Jyothi@sun-itsolutions.com.

 

Position: Test Method Validation Engineer

 

Rate:$35/hr on C2C

 

Location: Round Lake, IL

 

Duration: 12 Months

 

Hiring Mode: TP

 

About the Client:

Our Client develops, manufactures and markets products with the aim of saving and sustaining the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that help advance patient care worldwide.

 

About the Project:

1) Test Method Validation for all functional and interface test methods for Disposable products

2) Verification protocols, test cases, testing, data analysis, design Fixtures and final reports for Disposable products

3) Design Verification Report and Trace Matrix for Disposables products

 

Qualification: Bachelor's / Master’s Degree Mechanical Engineering or Bio Engineer

 

Job Description:

•       Minimum 2+ Experience in Medical domain (preferable in Disposables)

•       Experience in developing mechanical test methods

•       Experience in writing mechanical test protocols

•       Experience in Test Method Validation

•       Experienced in working on Medical disposables would be an advantage

•       Basic understanding in functional / system testing for medical devices

•       Experience in Validation and Verification Activities for Medical devices

•       Experience in writing reports

•       Basic understanding and experience on test setup

•       Good Communication, writing and documentation skills

 

Roles & Responsibilities:

•       Development of test methods for both standard s specific and product specific requirements

•       Carrying out Gauge R&R studies

•       Writing protocols & technical reports

•       Manage Requirements traceability matrix as applicable

 

 

Skills Matrix	Candidate Self Rating
	Years of Experience	Basic	Intermediate	Expert
Degree in Mechanical Engineering/ Bio-Science
Experience in Medical Domain
Mechanical Test Methods
Mechanical Design Experience
Mechanical Test Protocols
Test Method Validation
Mechanical Validation
Mechanical Verification
Mechanical Test Reports

 

 

 

 

 

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Thanks & Regards,
Jyothi 

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