Manufacturing Tooling Engineer

•    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.