Manufacturing Tooling Engineer

Job Title: Manufacturing Tooling Engineer Location: Raynham, MA JD as below • Looking for a mechanical/manufacturing engineer • Experience with process validation required • Experience with GD&T, CMM, gaging required • Experience with statistical analysis/Minitab preferred • Experience with CAD, NX preferred • Experience with Windchill preferred • Experience with fixture/gage design is a plus • Wax injection tooling/injection molding experience is a plus • Foundry experience is a plus Required Qualifications • Education: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline. • Experience: 3-7 years in manufacturing tooling, fixtures, gages, injection molding equipment validation in a regulated environment (MedTech, pharma, or healthcare devices). • Regulatory & Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ). • Technical Skills: o Proficiency in developing and executing IQ/OQ/PQ protocols. o Experience with fixtures, gages, injection molding, o Statistical tools experience (Minitab, JMP, or similar) for process capability studies. o Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.). • Communication: Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.

Created: 2026-03-17