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Mechanical Engineer
Ref No.: 18-55546
Location: Warsaw, Indiana
Position Type:Contract
Start Date: 08/03/2018
Job Title Mechanical Engineer
Relevant Experience
(in Yrs)
1-3 years
Technical/Functional Skills JDE system and report analysis
Change Management systems
Develop time standards and BOM verification
Info PV updates to validation documents
Knowledge of basic quality tools, risk analysis, statistics (SPC)
Ability to read and understand engineering drawings
Knowledge of Quality System requirements, ISO and FDA requirements (preferred)
Ability to effectively work within a team to expedite completion of critical project tasks with other functional groups
Experience with Statistical Process Control and inspection techniques
Experience Required 1-3 years
Roles & Responsibilities Work with value stream managers, operations, quality and planners to evaluate work center & operation job steps consolidations by profit center
Revise work centers, descriptions, profit center, queue & move times
Change Management
Revise operation codes
Job step
Measurement Instruction Sheet (MIS) / Incoming Inspection Sheet (IIS)
Factory net/ Delmia
Revise Router/BOMs to new work center & procedures
Revise work instructions
Revise time standards in JDE as needed based on evaluation
Validation Revisions (working with Validation Engineers)
Revise process flow charts with new work centers
Follow validation revisions through to closure
Interface with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.
Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.
Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools.
Generic Managerial Skills Not Mandatory
Education Bachelor of Science degree in Engineering (Mechanical or Industrial)
Start date (dd-mmm-yy) 6-Aug-18
Duration of assignment (in Months) 6 months
Work Location (State, City and Zip) Warsaw, IN 46580
Rates payable to vendor $/hr $ 35hr.
Key words to search in resume Medical Devices, Process Validation, IQ/OQ/PQ, 21 CFR Part 11, Statistical Analysis Tools, Inspection Techniques, SPC, Change Management System, JDE
Prescreening Questionnaire Questions on medical devices manufacturing and quality.