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