Manufacturing Engineer

 
Location: Brooklyn Park, Minnesota
Posted On: 3/15/2017
Job Code: MEN_MN_3255
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Job Description
 
Client : Leading Medical Device Manufacturing Company
Location : Brooklyn Center MN 55430
Duration : 03 Months (possibility of extension)
Job ID : Manufacturing Engineer II

Position description:
This position is responsible for monitoring and improving medical device manufacturing lines. The Manufacturing Engineer will work cross functionally with operations, development, and quality to identify opportunities for improvement and to address product issues through the product review board (PRB) process. The position will be responsible to work with manufacturing process owners to determine and implement preventative and corrective actions, as appropriate. Good documentation practices and experience working in the quality system for a regulated industry are required.

Position Responsibilities:
Job Duties/Responsibilities:
- Drive a Quality focused culture by monitoring compliance to Quality System processes, such as system transaction compliance (i.e. FACTORYworks), documentation practices, non-conforming material, product holds, Line Clearance, etc.
- Documents product review board (PRB) activities for non-conforming product.
- Accountable for implementing GMP (good manufacturing practices) that apply to a specific production area.
- Responsible for ensuring all Assemblers understand and follow GMP.
- Execute GMP mfg assessments.
- Participate in the Corrective/Preventative action process, as required.
- Recommends design modification and process changes where advisable to minimize cost and conform to production capabilities and limitations.
- Uses specialized scientific methods and instrumentation to analyze data, draw conclusions and conduct root cause analysis. Uses advanced math skills and intermediate statistics (process capability, DOE, Gage R&R studies, FMEA, principles, etc) to manipulate data
- Work closely with the Assembler team to understand issues and opportunities for improvement.


Education, Skills and Basic Experience Needed to Perform Position Function:
Bachelor of Engineering, or related science
- Minimum of 2 yrs. experience or MS degree and +2 years technical knowledge of manufacturing processes
- Aptitude for quickly learning and as simulating a broad array of information
- Experience comprehending and training others on Quality System Process Documents
- Experience understanding proper documentation/quality requirements for a regulated environment
- Strong written and verbal communication skills
- Technical knowledge of manufacturing processes
- Proficient with computer using MS Office (Word, Excel, PowerPoint)
- Experience interpreting mechanical drawings
- Experience conceiving and communicating mechanical design concepts to drafting team
- Knowledge of quality systems
- Aptitude for quickly learning and as simulating a broad array of information
- Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
- Experience comprehending Quality System Process Documents
- Experience understanding proper documentation/quality requirements for a regulated environment

Desirable Qualifications to Perform Position Function:
- Demonstrated ability to lead in FDA regulated environment/Assembly operations
- Lean, Six Sigma experience
- Knowledge of quality systems
- Experience interpreting mechanical drawings
- Experience understanding proper documentation/quality requirements for a regulated environment
- ISO 13485/GMP experience
- Experience conceiving and communicating mechanical design concepts to drafting team
- Experience with manufacturing systems such as JDE, FACTORYworks, or SAP.
- Experience in medical product mfg. / assembly operations
- Experience with preventative/corrective action process
- Understanding of Development Protocols-IQ/OQ/PQ
Category:Non-IT  code:new
 
 
Job Requirements
 
 
Training, MS Office, Compliance, Engineering, MS Word, SAP, ISO 9001, MS Excel, Assembler, Six Sigma, Data Analysis
 

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Contact Details
 
Recruiter
Vishnu Krishnan
 
Phone
 
 
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