Manufacturing Tooling Engineer
Listed on 2026-07-01
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Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer, Mechanical Engineer
Manufacturing Tooling Engineer
Location:
Raynham, MA
Job Description 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 (Med Tech, 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:
- Proficiency in developing and executing IQ/OQ/PQ protocols.
- Experience with fixtures, gages, injection molding.
- Statistical tools experience (Minitab, JMP, or similar) for process capability studies.
- Document control and eQMS systems experience (e.g., Master Control, ETQ, etc.).
Communication:
Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.
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