Sr. Tooling Engineer

Polyzen, Inc.; Apex (NC); On-site; USD 75,000 - 115,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(K) with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Disabled

Job summary

Polyzen, Inc. is seeking a Sr. Tooling Engineer to design, procure, and implement tooling for medical device manufacturing.

You will create CAD models in SolidWorks, troubleshoot tool failures, manage vendors and machinists, and lead projects from concept through production implementation. This role emphasizes on-time, cost-effective tooling solutions with strong cross-functional collaboration. The ideal candidate has 4–5 years of tool design experience in a regulated manufacturing environment,

Qualifications

• Bachelor's degree in mechanical engineering or related field.
• 4–5 years hands-on tool design experience in manufacturing.
• Experience with ISO 13485, FDA 21 CFR 820 is preferred.
• Proficiency using SolidWorks to design components and drawings.

Responsibilities

• Designs and implements tooling, dies, molds, fixtures for production.
• Procures tooling from internal shops and external vendors, oversees fabrication and integration.
• Maintains drawings and releases tools per latest specifications.
• Leads tooling projects to improve manufacturing processes and quality.
• Supports product development and validations for new equipment.

Skills

Mechanical design

Project management

Vendor management

Cross-functional collaboration

Documentation writing

Education

Bachelor's Degree in Mechanical Engineering

Tools

SolidWorks

MS Office

Job description

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.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

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.

What you will do:

• 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.

Who you are:

• 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
• 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.
• Generous Paid Time Off
• Annual Bonus
• 401(K) with excellent company match
• Health Insurance with multiple plans to choose form
• Paid Short Term and Long Term Disability