Manufacturing Engineer – Investment Casting & Mold Flow | Medical Devices

Responsibilities:

• Support investment-casting operations for orthopedic components, including wax injection, wax assembly, ceramic shell building, dewaxing, furnace operations, casting, finishing, and inspection.
• Develop, optimize, and qualify casting processes, including tooling, wax dies, gating, risers, fixtures, shell conditions, furnace parameters, and operating windows.
• Perform casting simulation and mold-flow analysis using ProCAST, MAGMASOFT, or equivalent tools to optimize filling, solidification, gating, runners, risers, and identify porosity, shrinkage, and hot-spot risks.
• Troubleshoot casting defects and drive improvements in yield, scrap, cycle time, capacity, and process stability using DOE, SPC, Lean, Six Sigma, and root-cause analysis.
• Lead/support process qualification and validation activities, including IQ/OQ/PQ, process characterization, requalification, validation protocols, sampling plans, acceptance criteria, and statistical capability studies (Cp/Cpk, Pp/Ppk).
• Support NPI, design transfer, tooling development, engineering changes, and production ramp-up while reviewing drawings, GD&T, specifications, PFMEA, control plans, and manufacturing requirements.
• Collaborate with R&D, Quality, Operations, suppliers, and external laboratories while ensuring compliance with FDA, ISO 13485, GMP, and medical-device quality-system requirements.

Required Skills:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Materials Engineering, Industrial Engineering, or a related field.
• 5–10 years of manufacturing or process-engineering experience.
• Strong experience in investment casting, foundry operations, or a related casting environment.
• Experience with casting process development, tooling, gating, risers, wax patterns, ceramic shells, and process qualification.
• Experience with casting simulation or mold-flow analysis using ProCAST, MAGMASOFT, or equivalent tools.
• Knowledge of process qualification, validation, and IQ/OQ/PQ activities.
• Proficiency in DOE, SPC, Cp/Cpk, Pp/Ppk, Minitab, and statistical analysis.
• Experience with CMM, GD&T, dimensional inspection, and CTQ analysis.
• Knowledge of PFMEA, DFMEA, control plans, root-cause analysis, and CAPA.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Strong understanding of tooling, dies, fixtures, and manufacturing process controls.
• Ability to review engineering drawings, specifications, BOMs, tolerances, and manufacturing requirements.
• Strong technical writing, problem-solving, communication, and collaboration skills.
• Ability to work effectively with R&D, Quality, Operations, suppliers, and external laboratories.
• Experience working in regulated manufacturing environments.

Education & Experience:

• Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Materials Engineering, Industrial Engineering, or a related discipline.
• 5 years of manufacturing or process-engineering experience.
• Strong investment-casting or foundry experience preferred.
• Demonstrated experience in tooling, casting-process development, process qualification, and manufacturing validation.
• Preferred experience in orthopedic or medical-device manufacturing.
• Hands-on experience with casting-simulation software will be an advantage