Manufacturing Engineer

NovintiX; Massachusetts; On-site; USD 100,000 - 140,000; Full time

Job summary

NovintiX is seeking a Manufacturing Engineer for Casting & Mold Flow in Raynham, MA. The role focuses on investment casting, process development, casting simulations, and quality validation within a regulated medical-device environment.

The candidate will lead DOE studies, utilize ProCAST/MAGMASOFT, and collaborate with R&D, Quality, and Operations to optimize yield, cycle time, and process stability. A strong mechanical engineering background and 5–10+ years in casting are preferred.

Qualifications

• 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 investment casting or foundry experience.
• Experience with casting process development, tooling, gating, and risers.
• Experience with casting simulation using ProCAST or MAGMASOFT.
• Knowledge of validation IQ/OQ/PQ and process qualification.
• Proficiency in DOE, SPC, Cp/Cpk, Pp/Ppk, Minitab.
• Experience with CMM, GD&T, and CTQ analysis.
• LEAN and Six Sigma methodologies.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Support investment-casting operations for orthopedic components.
• Develop, optimize, and qualify casting process parameters and operating windows.
• Evaluate wax, shell condition, mold temperature, and pouring conditions.
• Troubleshoot porosity, shrinkage, inclusions, and dimensional variation.
• Perform dimensional analysis and CTQ studies using CMM and Minitab.
• Drive yield, scrap, cycle time, capacity, and process stability with DOE/Lean.
• Support shell-room characterization and controls.
• Develop tooling, wax dies, gating concepts, fixtures.
• Lead or support QA activities for casting processes.
• Review simulations, correlate with production data and defects.
• Define simulation inputs and acceptance criteria.
• Work with R&D, Quality, Operations, suppliers and labs.
• Prepare validation protocols and final reports.

Skills

Investment casting

Foundry operations

Casting process development

Gating & riser design

Casting simulation

ProCAST

MAGMASOFT

DOE

SPC

Cp/Cpk

Minitab

CMM

GD&T

Lean Manufacturing

Six Sigma

IQ/OQ/PQ

Regulated environments

Technical writing

Cross‑functional collaboration

Education

Bachelor’s degree in Mechanical/Manufacturing/Materials/Industrial Eng or related field

Tools

ProCAST

MAGMASOFT

Job description

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