Mechanical Engineer I - 3D design NPI

Westborough, MA

Post Date: 10/29/2017 Job ID: 15123 Industry: Technical Pay Rate: $ 0.00 - $ 0.00

1. BS Degree in Mechanical, Electrical, Biomedical Engineering or related degree. 
2. Familiarity with ISO, FDA and other regulatory standards. 
3. Knowledgeable of a variety of manufacturing methods, including injection molding, extrusion, machining, and assembly processes. 
4. Proficient with 3D modeling software. 
5. Knowledge in statistics analysis, risk management and FMEA. 

Desired Characteristics:
1. Minimum 1-2 years progressive experience as an engineer in product development or sustaining engineering, with past experience designing and launching products. 
2. 1-2-years experience in project leadership within a manufacturing, development or research environment a plus. 
3. Demonstrated experience in plastic part design. 
4. Strong written and verbal communication skills. 
5. Experience working in stage gate development process and global project teams. 
6. Previous work experience in a matrixed-management/leadership environment. 
7. Experienced working in ISO9000 or 13485 environment, with regulatory compliance processes and creation of design history files. 
8. Self-starter, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues. 
9. DFSS or Green Belt/Black Belt Certification. 
10. Experience with Regulatory compliances of Single Use products for Bioprocessing.

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