Requirements
- Bachelor of Science in Mechanical Engineering, Plastics Engineering, or related field with more than five years of relevant experience.
- Experience complying with FDA, USDA, or other regulated manufacturing standards, particularly in diagnostics or biomedical device production.
- Demonstrated background in high-volume production methods and associated tooling systems.
- In-depth understanding of plastic material behaviors, injection molding techniques, and mold design fundamentals.
- Proven ability to manage and coordinate with external contract manufacturers and third-party vendors.
- Proficient in Moldflow simulation software for mold analysis and optimization.
- Skilled in using CAD platforms such as SolidWorks or AutoCAD for engineering design and documentation.
- Familiarity with Operational Excellence methodologies including DMAIC, 5 Whys, Fishbone diagrams, and FMEA.
- Ability to communicate and collaborate effectively across departments and organizational levels.
- Adaptability to shifting priorities and dynamic project demands in a fast-paced environment.
- Competent in standard computer applications including Excel, Word, MS Visio, JMP, Minitab, or equivalent analytical tools.
Nice to Have
- Hold a Green Belt or Black Belt certification in Lean or Six Sigma methodologies.
Work Arrangement
On-site
