Injection Molding Process & Tooling Specialist

Responsibilities

• 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.

Qualifications

• 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.

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.