Onsite Position | ISO 13485 & ISO 9001 Environment
Position Summary
The Tooling Engineer is responsible for the design, development, validation, and continuous improvement of injection molds and related tooling for medical device components. This role provides hands-on support in the toolroom, collaborates with internal and external tool shops, works closely with NPI customers, and ensures that molds are robust, compliant, and optimized for high-volume, high-precision manufacturing. The Tooling Engineer plays a critical role in supporting new product introductions (NPI), troubleshooting tooling issues, and driving technical excellence across the organization.
Key Responsibilities
Tool Design & Development
- Design and develop injection molds, mold components, fixtures, and precision tooling with a focus on manufacturability, performance, and cost efficiency.
- Create detailed 3D CAD models, 2D drawings, and technical documentation using CAD/CAM software (e.g., SolidWorks, CATIA, Mastercam).
- Collaborate with external tool builders and internal toolroom personnel during tool fabrication, assembly, and qualification.
- Review customer part designs and provide DFM recommendations to optimize mold design and manufacturing.
Toolroom & Manufacturing Support
- Provide hands-on support in the toolroom, including mold assembly reviews, mold teardowns, and inspections.
- Support and oversee preventive maintenance, repairs, and refurbishment activities on molds and tooling.
- Participate in mold trials, analyze results, and drive improvements in mold performance, part quality, and cycle efficiency.
- Troubleshoot mold and tooling issues in production, including dimensional deviations, tooling wear, part defects, and processing-related challenges.
New Product Introduction (NPI)
- Serve as a technical liaison with NPI customers, internal engineering, and project managers to support tool design, validation, and launch readiness.
- Support prototyping, pilot builds, and production validation activities to ensure tooling meets customer and regulatory requirements.
- Participate in PFMEA, design reviews, and process development to ensure robust mold designs for new programs.
Project & Process Management
- Manage tooling projects from concept through production, ensuring timelines, budgets, and quality expectations are met.
- Coordinate cross-functional efforts between engineering, quality, manufacturing, program management, purchasing, and tool shops— both internal and global.
- Identify and implement improvements related to tooling design, materials, manufacturing methods, and repairability.
Compliance & Documentation
- Develop and maintain complete tooling documentation, including CAD models, drawings, BOMs, mold trial reports, and validation records.
- Ensure compliance with ISO 9001, ISO 13485, and internal quality system requirements for all tooling activities.
- Support root cause analysis, CAPA, and continuous improvement initiatives related to tooling and mold performance.
Qualifications & Skills
- Bachelor’s degree in Mechanical, Plastics, Manufacturing Engineering, or related field; equivalent industry experience considered.
- 3+ years of experience in injection mold design, tooling engineering, or moldmaking; medical device or tight-tolerance molding preferred.
- Strong hands-on experience with injection mold design, troubleshooting, and toolroom practices.
- Proficiency in CAD/CAM software (SolidWorks, CATIA, Mastercam, or equivalent).
- Working knowledge of machining principles, GD&T, fits/tolerances, and precision measurement tools (CMM, micrometers, gauges).
- Solid understanding of mold materials, steel selection, mold components, hot runners, cooling design, and molding processes.
- Strong knowledge of ISO 9001 and ISO 13485 quality systems.
- Excellent analytical, problem-solving, communication, and project management skills.
Preferred Skills
- Experience with high-cavitation molds, hot runner systems, and complex medical device tooling.
- Familiarity with mold flow analysis, DFM/DFA principles, and scientific molding concepts.
- Ability to manage multiple tooling projects and work collaboratively with a global engineering network.
- Experience supporting automation, EOAT, or secondary operations related to medical molding.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
