Sr Tooling Engineer

Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle. 

The Sr. Tooling Engineer is responsible for design, procurement, and implementation of specialized tools, dies, molds, and fixtures to support manufacturing production, continuous improvement, and product development initiatives. This role will create CAD models, troubleshoot tool failures, and manage vendor and machinist relationships to ensure robust, on-time, and cost–effective tooling solutions. Additionally, this role takes ownership of projects from start to completion, for new tooling as well as modifications to existing tools.

• →Designs and executes custom tooling and fixturing using Solidworks.
• →Procures tooling through both internal (machine shop) and external (vendor) sources; oversees completion during fabrication, assembly, testing, and implementation phases.
• →Maintains current tooling designs and release of accurate/up-to-date drawings.
• →Leads tooling projects to improve Manufacturing processes, operator safety, and product quality.
• →Supports multiple product Development projects to meet customer timelines.
• →Translates internal design input requirements into completed tools and fixtures.
• →Works closely with Polyzen’s machinist to achieve set schedule goals per project.
• →Communicates with internal customers to ensure alignment around deliverables (scope, cost, and schedule).
• →Holds periodic design reviews with key stakeholders to present designs and ensure team alignment across project milestones from concept/feasibility to prototype to production design and implementation.
• →Complete the documentation package (drawings, tool qualifications, and asset paperwork) associated with new tools and fixtures, and release documents within the Quality system.
• →Assists with validations for new equipment, new products, and process improvements.
• →Knowledge of, and ability to operate basic shop machinery (drill press, band saw, hand tools) is required.
• →Knowledge of CNC machining methodology is required, but will not be required to operate.
• →Ability to design and assemble simple machines with electronics/controls integration is a plus.

• Bachelor's Degree in Mechanical Engineering or related field of study or a combination of equivalent hands-on related experience and education.
• Minimum of Four (4) to Five (5) years of hands-on tool design experience.
• Prior experience in medical device manufacturing or pharmaceuticals-related industry is preferred.

• Knowledge and Experience with Quality Management Standards, specifically ISO 13485:2016, ISO 9001:2015, FDA 21 CFR Parts 210, 211, and 820 is preferred.
• Ability to use SolidWorks solid modeling capabilities to design components and assemblies used in various manufacturing processes.

• Ability to use SolidWorks technical drawing capabilities to produce fabrication and assembly drawings
• Understanding proper material selection for tool design (aluminum, brass, stainless steel, Delrin, PTFE, etc.)
• Hands-on mechanical aptitude to both oversee and contribute to tool/fixture assembly and testing
• Ability to write reports and operational procedure documents for tooling and fixtures (IQ/OQ/PQ) and understand and document facilities requirements related to the tool/fixture installation.
• Ability to read and interpret blueprints and/or schematics.
• Aid in troubleshooting efforts regarding site machinery, which includes extrusion dies, RF welders, and additional cleanroom machinery.
• Strong project management aptitude; be able to lead projects from start to finish, maintain relationships with internal and external stakeholders, stay within budget parameters, and execute on project timelines.
• Strong analytical, organizational, and communication skills.
• Proficiency with Microsoft Office Suite products.
• Self-starter who can maintain personal organization; has strong time management skills and is effective in building strong relationships with coworkers.