Manufacturing Engineer – Investment Casting & Mold Flow | Medical Devices

Synstack Technologies; Raynham (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Synstack Technologies in the United States is seeking an experienced Process Engineer focused on investment casting for orthopedic components. You will support casting operations across wax injection to inspection, and drive process improvements.

You will develop and qualify casting processes, perform mold-flow analysis with ProCAST/MAGMASOFT, and lead DOE/ SPC analyses to improve yield, cycle time, and product quality. Relevant FDA/ISO experience preferred.

Qualifications

• Bachelor's degree in mechanical, manufacturing, materials, industrial engineering, or related field.
• 5+ years of manufacturing or process-engineering experience.
• Strong investment-casting or foundry experience preferred.
• Experience with tooling, casting-process development, process qualification, and manufacturing validation.
• Preferred experience in orthopedic or medical-device manufacturing.
• Hands-on experience with casting-simulation software.

Responsibilities

• Support investment-casting operations for orthopedic components across wax injection to inspection.
• Develop, optimize, and qualify casting processes including tooling, gating, risers, and shells.
• Perform casting simulation and mold-flow analysis with ProCAST or MAGMASOFT to optimize filling and identify risks.
• Troubleshoot defects and drive improvements in yield, scrap, cycle time, and stability using DOE, SPC, Lean, and Six Sigma.
• Lead or support process qualification/validation activities (IQ/OQ/PQ) and CAPA.
• Support NPI, design transfer, tooling, changes, and ramp-up while reviewing drawings, GD&T, PFMEA, and control plans.
• Collaborate with R&D, Quality, Operations, suppliers, and labs while ensuring FDA/ISO 13485, GMP compliance.

Skills

Process engineering

DOE

SPC

Root cause analysis

Statistical analysis

Technical writing

Communication

Collaboration

Lean Six Sigma

Education

Bachelor’s degree in Mechanical Engineering / Manufacturing Engineering / Materials Engineering / Industrial Engineering

Tools

ProCAST

MAGMASOFT

Minitab

Job description

• 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