Principal Molding & Tooling Engineer

Syntagma Group; West Virginia; On-site; USD 110,000 - 150,000; Full time

Job summary

Syntagma Group is seeking a Principal Molding & Tooling Engineer to lead tooling design and process development for precision injection molding. You will drive equipment qualification, DOE studies, and continuous improvement across manufacturing, while mentoring engineers and ensuring regulatory compliance.

The role emphasizes NPI collaboration from development through production launch, with oversight of tooling strategies, capital investments, and cross-functional teamwork in a fast-paced

Qualifications

• Bachelor’s degree in a relevant technical field or equivalent combination of education and experience.
• Minimum of 5 years of relevant experience in injection molding, tooling, or manufacturing engineering.
• Strong knowledge of mold design, process optimization, equipment troubleshooting, and validation methodologies.
• Experience with root cause analysis, process capability studies, and continuous improvement.
• Ability to communicate effectively in English.
• Onsite position with standard Monday–Friday business hours (8:00 a.m.–5:00 p.m. ET).

Responsibilities

• Design, develop, and optimize precision injection molds, tooling, and molding processes.
• Lead tooling improvements, equipment qualifications, validations, and troubleshooting.
• Conduct process capability studies, design of experiments (DOE), root cause analysis, and IQ/OQ/PQ validations.
• Oversee molding trials, process documentation, and raw material evaluations.
• Drive continuous improvement initiatives to reduce defects, increase throughput, and improve reliability.
• Evaluate new tooling technologies, automation solutions, and auxiliary equipment.
• Develop capital investment recommendations, cost justifications, and tooling standardization strategies.
• Support NPI from development through production launch, managing timelines, risks, and cost targets.
• Collaborate with suppliers, contract manufacturers, and cross-functional teams to implement effective manufacturing solutions.
• Mentor engineers and technicians on molding, tooling, and process development best practices.
• Ensure compliance with applicable safety, quality, regulatory, GxP, SOP, and change-control requirements.

Skills

Mold design

Process optimization

Equipment troubleshooting

Validation methodologies

Root cause analysis

DOE

Education

Bachelor's degree in engineering

Job description

The Principal Molding & Tooling Engineer serves as a technical expert in injection molding, mold design, and manufacturing optimization. This role leads tooling and process development, supports new product introduction (NPI), and drives improvements in quality, efficiency, automation, and cost across manufacturing operations. The position also provides technical leadership and ensures compliance with applicable medical device quality and regulatory requirements.

Key Responsibilities

• Design, develop, and optimize precision injection molds, tooling, and molding processes.
• Lead tooling improvements, equipment qualifications, validations, and troubleshooting.
• Conduct process capability studies, design of experiments (DOE), root cause analysis, and IQ/OQ/PQ validations.
• Oversee molding trials, process documentation, and raw material evaluations.
• Drive continuous improvement initiatives to reduce defects, increase throughput, and improve reliability.
• Evaluate new tooling technologies, automation solutions, and auxiliary equipment.
• Develop capital investment recommendations, cost justifications, and tooling standardization strategies.
• Support NPI from development through production launch, managing timelines, risks, and cost targets.
• Collaborate with suppliers, contract manufacturers, and cross-functional teams to implement effective manufacturing solutions.
• Mentor engineers and technicians on molding, tooling, and process development best practices.
• Ensure compliance with applicable safety, quality, regulatory, GxP, SOP, and change-control requirements.

Qualifications & Requirements

• Bachelor’s degree in a relevant technical field or equivalent combination of education and experience.
• Minimum of 5 years of relevant experience in injection molding, tooling, or manufacturing engineering.
• Strong knowledge of mold design, process optimization, equipment troubleshooting, and validation methodologies.
• Experience with root cause analysis, process capability studies, and continuous improvement.
• Ability to communicate effectively in English.
• Onsite position with standard Monday–Friday business hours (8:00 a.m.–5:00 p.m. ET).