Hi,


I hope you are doing great,



I have an urgent requirement from one of my esteem client, I will
appreciate if you can have an eye on the below requirement and send me your
updated profile ASAP.



*Job Title: Sr. Mechanical Engineer with Medical Domain *

*Location: Dr. Tucson, AZ*

*Duration: Long Term Contract *



*Job Description:*

·         Experience in New Product Development, Product Sustenance

·         Has experience on DHF remediation project, good understanding of
design control requirements and Regulatory requirements

·         Perform/guide team in performing engineering activities such as
tolerance analysis, drawing updates, labelling, packaging.

·         Ability to apply and interpret the GD&T Controls and 1D Tolerance
Stack up as per Worst Case and RSS

·         Proficient usage of 3D CAD design tools – SolidWorks 2018 and PLM
Tools

·         Create/customize checklists to perform the gap assessment with
respect to ROCHE QMS and IVDR requirements (along with the core team)

·         Develop the remediation/implementation plan with System and Cross
functional team

·         Support in remediation of Requirements – For example: System, HW
requirements, Plan Documents – Product level and Functional level, Review
and update Input and Output documents including manufacturing drawings,
System Verification and Functional verifications documents, and establish
traceability.

·         Develop the remediation on DHF documents with respect to
Mechanical Function – ME Requirements, Drawings, Materials, Functional
Verification protocols/reports, Usability, Labeling, packaging,
Coordination with the Offshore team

·         Process and Product understanding

·         Custom-built test instrument design and documentation

·         Manual testing

·         Interfacing with Roche team in the US and be the SPOC for project
activities.

·         Review deliverables and provide updates to Roche on progress

·         Coordinate clarification requests from offshore team in
discussion with customer

·         Communicate priority, schedule, and ensure compliance working
closely with offshore team



Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

W: (972) 393-2255

E:  [email protected]

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

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