Senior Tooling Engineer | Medical Device CAD Lead

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, 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,