Manufacturing Engineer

Job Title: Manufacturing Engineer – Casting & Mold Flow Location: Raynham, Massachusetts, USA About the Company: NovintiX is a fast-growing engineering and digital transformation company serving top Life Sciences, MedTech, and Healthcare clients across the US, Ireland, and Europe. We specialize in delivering high-impact digital programs, engineering services, and talent solutions that accelerate innovation, efficiency, and compliance. Responsibilities: Support investment-casting operations for orthopedic components, including wax pattern creation and injection, wax assembly, ceramic shell building, controlled drying, dewaxing, furnace operations, casting, finishing, and inspection.Develop, optimize, and qualify casting process parameters and operating windows.Evaluate the impact of wax, shell condition, mold temperature, alloy and pouring conditions, solidification, and cooling on casting quality.Troubleshoot casting defects such as porosity, shrinkage, inclusions, dimensional variation, surface defects, yield loss, and scrap.Identify critical-to-quality characteristics and perform dimensional analysis and process capability studies using CMM, gaging data, Minitab, or equivalent statistical tools.Drive improvements in foundry yield, scrap, cycle time, capacity, and process stability using DOE, SPC, Lean, and Six Sigma methodologies.Support shell-room process characterization, including drying time, temperature, and humidity controls.Develop and optimize tooling, wax dies, gating and riser concepts, fixtures, and manufacturing aids.Support technical transfers, engineering changes, process changes, and manufacturing scale-up.Perform or review casting simulation and mold-flow analyses related to filling, solidification, thermal behavior, shrinkage, porosity risk, and hot spots.Use simulation results to optimize part orientation, gating, runners, risers, feeders, shell configuration, and critical process parameters.Correlate simulation results with production casting results, CTQ data, inspection findings, and defect mechanisms.Define simulation inputs, assumptions, material and process parameters, boundary conditions, and acceptance criteria.Use or support ProCAST, MAGMASOFT, or equivalent casting-simulation software.Review supplier or internal simulation models, technical reports, and recommendations.Translate simulation outputs into tooling, process-development, and manufacturing decisions.Support qualification and validation of revised tooling and casting process conditions.Perform sensitivity studies and DOE to establish robust process windows and identify critical-to-quality parameters.Lead or support IQ, OQ, and PQ activities for casting, wax, shell, furnace, tooling, inspection, and associated manufacturing processes.Develop validation protocols, sampling plans, acceptance criteria, process-characterization plans, and final reports.Establish Cp, Cpk, Pp, Ppk, SPC, and statistical controls for critical process parameters and product CTQs.Ensure validated processes remain within approved operating and control limits.Support process requalification when required due to changes in equipment, tooling, materials, suppliers, or process parameters.Support qualification of wax-injection equipment, shell-room equipment, furnaces, casting equipment, inspection equipment, molds, dies, and fixtures.Develop URS, risk assessments, equipment qualification documents, and FAT/SAT support documentation where applicable.Provide technical direction to tooling and casting suppliers.Review tooling designs, first-article results, process-trial data, and supplier corrective actions.Support tooling and gating design, mold and die modifications, and supplier technical assessments.Support new product introduction, design transfer, product launch, and production ramp-up for orthopedic components.Review engineering drawings, GD&T, specifications, BOMs, tolerances, and manufacturing requirements.Participate in DFM, design-for-casting, PFMEA, control-plan development, and process-risk assessments.Support engineering changes involving casting methods, materials, tooling, gating, process parameters, and inspection methods.Work in accordance with FDA, ISO 13485, GMP, and applicable medical-device quality-system requirements.Support NCR, CAPA, deviation, complaint, and manufacturing investigations involving casting and tooling processes.Apply 5-Why, Fishbone, DOE, statistical analysis, and engineering judgment to resolve complex manufacturing issues.Prepare technical assessments, validation reports, work instructions, process specifications, and change-control documentation.Collaborate with R&D, Quality, Operations, suppliers, and external laboratories.Communicate technical findings and recommendations through reports, presentations, and cross-functional reviews. 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