- Solid injection-molded plastic design expertise, including DFM/DFA, tooling interaction, material selection, and high-volume manufacturing experience.
- Hands-on CAD proficiency (SolidWorks or Creo) with solid understanding of GD&T;, tolerance stack-up, drawings, BOM management, and engineering change processes.
- Experience in regulated environments (medical/life sciences preferred) with knowledge of ISO 13485, 21 CFR, GMP/QMS, and design control processes (DHF, traceability).
- Verification & Validation ownership, including DVP/DVP&R; development, test protocol execution, and design verification/validation activities.
- Strong analytical and statistical capability, including MSA, SPC, Gage R&R;, DFSS, and data-driven problem-solving using tools like Minitab.
- Cross-functional collaboration and technical leadership, with sound engineering judgment and experience supporting mold/process validation (IQ/OQ/PQ, DOE preferred)