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 : 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

Employment Type : Full Time

Experience : years

Vacancy : 1