Drafter

PMT Corporation • Chanhassen, MN

3d

About The Position

The Drafter creates and maintains SolidWorks models, engineering drawings, and related technical documentation for medical devices, accessories, tooling, and fixtures used in PMT’s neurological, orthopedic, and plastic/reconstruction 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.

Requirements

• Two-year degree or certificate in drafting, CAD design, engineering technology, or a related field; equivalent experience is considered.
• At least 2 years of drafting experience using SolidWorks.
• 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

• Drafting experience in medical device or other regulated manufacturing.
• 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 per ASME Y14.5 and drafting practices per ASME Y14.100 and PMT drawing standards.
• Revise drawings and models to reflect design changes, corrective actions, and manufacturing improvements.
• Prepare and process Change Controls for drawing, specification, and procedure revisions.
• 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 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.
• 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
• Education Level: Associate degree