Principal Molding & Tooling Engineer

Role details

Position Summary

*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).
• Travel up to 10%.
• Relocation assistance available.
• Visa sponsorship is not available.