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Need || Manufacturing Engineer || Warsaw, IN(onsite) at Warsaw, Indiana, USA
Email: [email protected]
http://bit.ly/4ey8w48
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From:

Nikhil Singh,

Smartit frame

[email protected]

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Open for C2C and W2

All VISA Workable

Hello,

Job title: Manufacturing Engineer

Job location: Warsaw, IN(onsite)

Duration:12+ months

Technical/Functional Skills         

Medical devices technical transfer experience

Experience supporting medical device manufacturing

Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ

NCR/NCE creation, review, and disposition

Specific experience with Test method Validation and Gage R&R

Experience with root cause analysis and problem-solving for both technical and process issues

Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003

Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner

Good problem-solving skills through the use of quality and statistical tools

BOM & Router creation and update

Ability to read and understand engineering drawings

Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis

Knowledge of Quality System requirements, ISO and FDA requirements

Ability to effectively work within a cross-functional team to complete critical project tasks

Demonstrates good written and verbal communication skills

Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts

Microsoft Office Suite and Project

Experience Required    

2 - 4 years in medical devices manufacturing

Roles & Responsibilities              

Equipment transfers

Process characterization, equipment IQ/OQ, process OQ, and PQ

Test method Validation, Gage R&R, SPC

Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.

Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements

Establishing and improving process methods that meet performance and quality requirements

Execute equipment qualification or process validation project(s)

Thanks & Regards

Nikhil Singh

732-99-23184. Ext 154

[email protected]

Keywords: rlang wtwo
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11:07 PM 03-Aug-23


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Location: Warsaw, Indiana