Manufacturing Engineer Ii

Location
Chanhassen
Posted
Sep 07, 2017
Closes
Oct 07, 2017
Ref
299145
Contact
Ware Technology Services
Category
Engineering
Job Type
Employee
Employment Status
Full Time
Ware is searching for an experienced Manufacturing Engineer for a contract opportunity with a medical device company located in Chanhassen. You will provide manufacturing engineering support to manufacturing lines producing Class 1 medical devices used for remote patient monitoring. 

POSITION RESPONSIBILITIES: 
- Perform Equipment Installation, Mfg Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation for manufacturing equipment and processes. Generate all related documentation in compliance with internal and external requirements. 
- Interact with the manufacturing teams providing hands-on support and troubleshooting of manufacturing processes and equipment.
- Provide detailed engineering analysis and documentation in the management of material disposition, manufacturing process updates, qualification activities, compliance activities, and CAPA's. 
- Drive Continuous Improvement to improve the efficiency of the manufacturing processes and quality of the product.
- Identify cost savings opportunities and implement changes. Develop technical solutions to difficult problems, finding solutions that are thorough, practical, and consistent with organization objectives. 

BASIC QUALIFICATIONS: 
- BS in Engineering (Biomedical Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Electrical Engineering, etc.)
- 5+ years engineering experience in the medical device field operating under FDA QSR and ISO13485 requirements. 
- Experience with manufacturing process qualification (IQ/OQ/PQ), Software Validation, and Test Method Validation 

DESIRED/PREFERRED QUALIFICATIONS 
- Experience with Continuous Improvement and in leading cost savings efforts related to manufacturing processes 
- Experience with Lean Manufacturing
- Knowledge / experience with one or more of the following:  Mechanical Assembly of Electro-mechanical devices, Automated testing stations, Calibration of devices, Adhesive application, Packaging, Labeling.


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