Mechanical Engineer I - 3D design NPI
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.
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.