Drafter

PMT Corporation • Chanhassen, MN

7h

About The Position

PMT Corporation is seeking a Drafter to create and maintain SolidWorks models, engineering drawings, and related technical documentation for medical devices, accessories, tooling, and fixtures used in its neurological, orthopedic, and plastic and reconstructive surgery product lines. The role works closely with Product Development Engineering, Quality, and Manufacturing to ensure documentation is accurate, controlled, and compliant with PMT’s Quality System and applicable regulatory requirements.

The Drafter prepares and revises models, drawings, bills of materials, specifications, and controlled documentation; supports design documentation and verification, inspection, manufacturing, supplier communication, and regulatory submissions; and maintains CAD files, templates, and drawing libraries. The position may also produce illustrations and graphics for work instructions, Instructions for Use, labeling, and sales materials. Duties and responsibilities may change at any time with or without notice.

Requirements

• Two-year degree or certificate in drafting, CAD design, engineering technology, or a related field; equivalent experience is considered.
• Minimum of 2 years of drafting experience using SolidWorks, preferably in medical device or other regulated manufacturing.
• Working knowledge of GD&T (ASME Y14.5) and standard drafting practices.
• Experience with revision control, Change Controls/ECOs, and document control systems.
• Ability to read and interpret engineering sketches, specifications, and manufacturing processes such as machining and molding.
• Strong attention to detail, accuracy, and organization.
• Good written and verbal communication skills.
• Strong personal computer skills, including SolidWorks and Microsoft Word, Outlook, and Excel.

Nice To Haves

• Familiarity with FDA, ISO 13485, and GMP documentation requirements.
• Experience with AutoCAD DraftSight.
• Certified SolidWorks Associate (CSWA) or Certified SolidWorks Professional (CSWP).

Responsibilities

• Create 3D models, assemblies, and detailed 2D engineering drawings in SolidWorks from sketches, existing drawings, markups, prototypes, and design concepts.
• Prepare part, assembly, packaging, label, and inspection drawings for medical devices and accessories.
• Apply GD&T in accordance with ASME Y14.5, drafting practices in accordance with ASME Y14.100, and PMT drawing standards.
• Revise existing drawings and models to reflect design changes, corrective actions, and manufacturing improvements.
• Prepare and process Change Controls to document revisions to drawings, specifications, and procedures.
• Maintain revision control of drawings, models, and Bills of Materials in PMT’s document control system.
• Create and maintain BOMs, component specifications, and part numbers for new and existing products.
• Support Design History File and Device Master Record documentation through required design stages.
• Assist with design input and design output documentation and verifications.
• Create drawings for tooling, fixtures, gauges, and manufacturing equipment, including new and repaired tooling.
• Prepare drawings and specifications for suppliers and communicate with suppliers and vendors to clarify drawing requirements.
• Create drawings for customer-requested non-standard or custom devices.
• Check drawings for accuracy, completeness, and conformance to standards before release.
• Support inspection by providing drawings, dimensional callouts, and inspection criteria to Quality and inspectors.
• Produce illustrations and graphics for work instructions, Instructions for Use, labeling, and sales materials as needed.
• Provide documentation support for FDA 510(k) submissions and Quality System audits.
• Support investigations of non-conformity reports and product complaints by reviewing drawings and specifications.
• Comply with applicable regulatory requirements and quality systems, including GMP, ISO 13485, FDA, and MDR requirements described in PMT documentation.
• Organize and maintain CAD file structure, templates, and drawing libraries.
• Perform other duties and responsibilities as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree