Manufacturing Engineer

Location: Chanhassen, Minnesota
Posted On: 9/11/2017
Job Code: ME_MN2128
Job Description
The Manufacturing Engineer will provide manufacturing engineering support to manufacturing lines producing Class 1 medical devices used for remote patient monitoring.

The manufacturing operations involved are for the production of electro-mechanical devices and may include the following:
• Mechanical Assembly of Electro-mechanical devices
• Automated testing stations
• Calibration of devices
• Adhesive application
• Packaging
• Labeling

Primary: Perform Equipment Installation, Mfg Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities for manufacturing equipment and processes. Generate related documentation including Master Validation Plans, pFMEA’s, and Work Instructions.
Secondary: Software Validation and Test Method Validation.
Generate all related documentation in compliance with internal and external requirements.
Daily interaction 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.

Ensure personal understanding of all applicable quality policy and quality system procedural requirements. Complete required training on time.

- BS in Engineering
- 5 years minimum 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

- Experience with Continuous Improvement and in leading cost savings efforts related to manufacturing processes
- Experience with Lean Manufacturing
Category:IT  code:new
Job Requirements
Engineering, HTML, Compliance, Management, Training, COM, STE

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Contact Details
Ebrahim Sayarwala