Sr. Tooling Engineer

This position is based in or near Ontario, California. Candidates must reside within a commutable distance to Ontario.

POSITION SUMMARY

The Senior Tooling Engineer will be responsible for supporting our CM’s on the maintenance of our current injection molding tooling fleet as well as the design, development, and optimization of new plastic injection molds and tooling for high-volume manufacturing of our plastic consumables. This role requires extensive experience in tooling design and manufacturing processes. We are looking for a highly motivated candidate, who can work cross-functionally.

IMPACT AND ORGANIZATIONAL CONTRIBUTION

• Define and standardize tool maintenance/cleaning process and hold suppliers accountable.
• Drive root cause analysis and issue resolution to common tool issues/downtime to guide suppliers on optimal path forward.
• Create and track spare tool/part inventory and strategy.
• Benchmarking common repair/troubleshooting activities across suppliers to ensure minimum downtime.
• Identify weak areas in each tool or problem tools, once we have buffer, to proactively fix tools before they go down for repair.
• Manage tool health and create tool retirement plan.
• Create way to get better real-time visibility to tool status and performance, including use of in-mold sensors for monitoring.
• Review and approve tool design and Moldflow for each new tool and supplier before we cut steel.
• Identify best practice in terms of mold design and standardize across all suppliers.
• Optimize tooling designs for manufacturability, cost-efficiency, and quality and implement lessons learned from previous tools.
• Oversee the fabrication, testing, and validation of new molds and tooling.
• Track mold build activities and ensure compliance to schedule.
• Support tool bring-up on-site at suppliers to aid them through the process and to solve issues as they arise.
• Own the mold design CAD as well as 2D files and update them as needed.
• Implement continuous improvement initiatives to enhance tooling performance and reduce cycle times.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure tooling designs meet product specifications and regulatory requirements.
• Conduct feasibility studies and risk assessments for new tooling projects.
• Strong ability to investigate root cause of production issues impacting product quality or yield, support implementation of improvements, countermeasures, and preventative action.
• Identify sources of variation (procedure, process, equipment, people) within the manufacturing process and design solutions.
• Recognizes need for and embraces concept of continuous improvement. Creates new ideas and recommendations based on engineering data, facts, and observations.
• Collects process data and performs trending and statistical evaluation to monitor process performance to understand stability and areas for improvement.
• Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company.
• Maintain quality control and safety standards.
• Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.
• Assists in completing validation activities as required.
• Assists in non-conformance and CAPA investigations.

EDUCATION AND EXPERIENCE

• BS in Mechanical Engineering, Plastics Engineering with 5+ years of experience.
• Food and Drug Administration, USDA and/or work in a regulated manufacturing environment, preferably in the diagnostics or biodevice industry, is required.
• Proven experience with high-volume manufacturing processes.
• Strong knowledge of plastic materials, injection molding processes, and tooling design principles.
• Experience in working with contract manufacturing organizations and third-party suppliers.
• Proficiency in Moldflow
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD).
• Experience with Operational Excellence tools such as DMAIC, 5 why’s, Fishbones, FMEA, etc.
• Green belt or Black belt certification is a plus.
• Demonstrated ability to interact effectively with colleagues and management across departmental boundaries.
• Candidate must possess flexibility and agility to respond to constantly changing conditions and priorities.
• Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, or similar software

PHYSICAL POSITION REQUIREMENTS

• Must reside within a commutable distance to Ontario, CA.
• Travel as required to fulfill responsibilities of the role