Manufacturing Tooling Engineer
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Job Location:
Raynham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Manufacturing Tooling Engineer
Location: Raynham MA
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: Bachelors 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
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: Bachelors 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
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
