The Manufacturing Engineer II (Transfer) is responsible for supporting the development of manufacturing methods for the introduction of new products, the transfer of existing products, or cost reduction projects, adhering to FDA 21 CFR part 820 guidelines (Good Manufacturing Practices).
The successful candidate will demonstrate planning and execution skills to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met.
Lead project meetings and pFMEA teams
Knowledge of process characterization (Cpk), process validations
Analyze and troubleshoot data from process characterization and make recommendations based on output
Support Quality Engineering in completion of MSA tasks and control plan development
Assist with the development of Capital Expenditure Requests
Assist with development of process characterization and validation protocols
Bachelor of Science in Engineering or Engineering Technology
Minimum of two years in Engineering
Proficiency in the use of Microsoft based applications such as, but not limited to, Word, Excel, and Project
Other Preferred Job Skills/Functions:
Experience/knowledge with process characterization, analysis, control and validation utilizing statistical tools (Six Sigma methodologies and experience)
Experience with Process Maps, pFMEA, MSA and/or other risk analysis tools
Design experience - can be product, fixturing, gauging, tooling, etc.
Data analysis & critical thinking skills
Materials experience/knowledge with manufacturing using (all or some)Titanium, Cobalt Chrome, Stainless Steels, medical grade plastics, etc.
Process experience/knowledge with (all or some): machining of metals and/or plastic (e.g. lathe, mill, CNC, EDM, multi-axis equipment), casting, forging, grinding, finishing, assembly, etc.
Engineering & Research
Smith & Nephew Inc. - 22 months ago