Injection Molding Process & Tooling Specialist

Responsible for supporting and leading continuous improvement initiatives, centered on injection mold tooling & process, to achieve safety, quality, delivery, and cost objectives within a regulated medical device manufacturing environment. Partners closely with Quality and Operations as a technical subject matter expert in molded plastic components, mold design, process validation, and manufacturing optimization. Ensures reliable production performance through effective tooling maintenance strategies, spare parts management, root cause problem solving, and process improvements that enhance product quality and equipment operational efficiency.

• Provide advanced technical leadership for the optimization, validation, and sustainment of injection molding processes and tooling for high-precision medical device components.
• Lead tooling lifecycle management activities, including qualifications, validation (IQ/OQ/PQ), preventive maintenance, repair, refurbishment, and replacement planning.
• Troubleshoot complex molding, tooling, and process-related issues to minimize downtime, reduce scrap, improve yield, and ensure consistent product quality and manufacturing reliability.
• Drive continuous improvement initiatives focused on safety, quality, delivery, cost reduction, process capability, tooling life cycle, and overall equipment effectiveness (OEE).
• Evaluate and implement tooling and process enhancements to improve manufacturing performance and cost efficiency.
• Establish and maintain tooling standards, specifications, CAD models, assemblies, drawings, work instructions, and various molding process parameters.
• Develop and execute data-driven tooling maintenance strategies through monitoring shot counts, tool condition, dimensional performance, and maintenance history to proactively manage tool life.
• Drive tooling spare parts strategies, inventory planning, and replacement component forecasting to ensure uninterrupted production and sustained product quality.
• Manage relationships with tooling suppliers and repair vendors, including sourcing competitive quotations, coordination of repairs, validating vendor work, and monitoring supplier performance.
• Establish, manage, and maintain tooling maintenance and repair budgets while identifying opportunities for cost savings and improved asset utilization.
• Serve as the site subject matter expert for injection molding and tooling systems, providing technical guidance, floor support, and training to production and maintenance teams.
• Review tooling dimensional and performance data to ensure compliance with internal specifications, regulatory requirements, and customer quality standards.
• Facilitate effective communication and coordination across departments and multi-shift operations regarding tooling status, priorities, corrective actions, and continuous improvement initiatives.
• Provide leadership, mentoring, and oversight for dry process manufacturing technicians, including capability development and training activities to support production and operational goals.

Travel Requirement:

• This position may require local or global travel as needed, less than 5% annually.

Knowledge, Skills and Abilities:

• Demonstrates a positive, proactive attitude with strong leadership and mentoring capabilities, including training and developing cross-functional team members.
• Excellent verbal, written, and presentation skills with the ability to prepare clear, concise, and data-driven technical reports, analyses, and recommendations.
• Proven ability to communicate complex technical concepts effectively to technical and non-technical stakeholders, including customers, suppliers, and management.
• Proficient in engineering and business software, including SolidWorks, Microsoft Office Suite, Mastercam, and Microsoft Project.
• Applies sound judgment and a logical, structured approach to problem-solving and decision-making while maintaining appropriate prioritization and business perspective.
• Skilled in identifying root causes, analyzing data, establishing facts, and implementing effective corrective and preventive actions.
• Adaptable and resilient in fast-paced environments with changing priorities and competing demands.
• Strong analytical, organizational, and project management skills, with a high degree of initiative, accountability, and personal integrity.
• Self-motivated, detail-oriented, and results-driven, with a proven ability to manage multiple projects and consistently meet deadlines.
• As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.

Work Environment:

This position operates in a manufacturing environment that involves working with injection molding machines, automated production equipment and moving mechanical systems. The role is primarily performed indoors within controlled Class 8 environments, having moderate to high noise levels, and occasional exposure to chemicals and solvents.

• Familiar working in environment utilizing injection molding equipment.
• Climate controlled medical device manufacturing environment.
• Occasional exposure to common chemicals and solvents used to maintain injection mold tooling and work area.
• Perform moderate physical activities – standing, walking, bending, kneeling, crouching, twisting, and climbing.
• Spend majority of the workday standing and walking.
• Ability to lift and move materials weighing up to 50 pounds on an occasional basis.

Experience:

• 5+ years of progressive experience in plastic injection molding and tooling. Ideal candidates will have experience in tooling &/or mold design, build, injection molding process, and advanced troubleshooting in a production environment.
• Scientific Molding certification &/or training is desired but, not required.
• Experience supporting manufacturing operations within regulated industries, including medical device environments, with familiarity in quality management systems and regulatory standards such as ISO 9001, ISO 13485, and MDSAP.

Education:

• Associate degree or technical certification is preferred; OR a combination of education, technical expertise and experience.

The hourly pay range for this position is $28 to $41.00 per hour. Compensation offered will be determined based on factors such as relevant experience, skills, qualifications, and education.