Manufacturing Engineer

Location
Columbia Heights
Posted
Sep 07, 2017
Closes
Oct 07, 2017
Ref
299280
Contact
Ware Technology Services
Category
Engineering
Job Type
Employee
Employment Status
Full Time
Are you an experience Manufacturing Engineer looking for your next challenge? Ware is working with a medical device company that has a location in the north metro which is seeking a Manufacturing Engineer on contract for approximately 6 months. In this role, you will provide manufacturing engineering support to manufacturing lines producing Class III long term implantable medical devices. 

POSITION RESPONSIBILITIES: 
- Interact with the manufacturing teams providing hands-on support and troubleshooting of manufacturing processes, tooling and equipment.
- Provide detailed engineering analysis and documentation in the management of material disposition, manufacturing process updates, qualification activities, compliance activities, and CAPA's.
- Work with the calibration and maintenance groups to ensure that equipment maintenance and calibration is completed on time.
- Work with manufacturing quality engineers to investigate statistical signals as a part of production control and monitoring. 
- Perform Equipment Installation, Manufacturing 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. 
- Support manufacturing facility transfer and product transfer activities to offshore facilities. 
- Develop technical solutions to difficult problems, finding solutions that are thorough, practical, and consistent with organization objectives. 

BASIC QUALIFICATIONS: 
- BS in Engineering 
- 5 years minimum engineering experience in the medical device field 
- Experience with manufacturing process qualification (IQ/OQ/PQ), Software Validation, and Test Method Validation 
- Experience with Class III medical device manufacturing 
- Experience with the FDA QSR and ISO13485 

DESIRED/PREFERRED QUALIFICATIONS: 
- Experience with component cleaning (isopropyl alcohol, micro 90) and/or passivation 
- Experience with medical device production line support

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