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PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets. Our workplace is a community of innovators who are passionate about creating an impact. We recognize that the collective power of our team is what propels us forward. Together, we celebrate successes, learn from challenges, and continuously evolve in our pursuit of excellence.
Join us at PMT Corporation if you're ready to be a part of a collaborative, idea-driven, and communicative environment. Your innovation matters, and together, we can continue to shape the future of the medical device industry.
DRAFTER OVERVIEW:
This position is responsible for creating and maintaining SolidWorks models, engineering drawings and related technical documentation for medical devices, device accessories, tooling and fixtures used in PMT's neurological, orthopedic, and plastic / reconstruction surgery product lines. The SolidWorks Drafter works closely with Product Development Engineering, Quality and Manufacturing to ensure drawings and documentation are accurate, controlled and compliant with PMT's Quality System and applicable regulatory requirements.
DUTIES OF THE DRAFTER (Include but not limited to):
- Create 3D models, assemblies and detailed 2D engineering drawings in SolidWorks from engineer sketches, detailed drawings on outdated drawing templates, markups, prototypes and design concepts.
- Prepare part, assembly, packaging, label and inspection drawings for medical devices and accessories.
- Apply Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 and drafting practices per 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 (CC) to document drawing, specification and procedure revisions.
- Maintain revision control of drawings, models and Bills of Materials (BOMs) within PMT's document control system.
- Create and maintain BOMs, component specifications and part numbers for new and existing products.
- Support Design History File (DHF) and Device Master Record (DMR) documentation through each required design stage.
- 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; communicate with suppliers 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 (IFU), labeling and Sales materials, as needed.
- Provide documentation support for FDA 510(k) submissions and audits of the Quality System.
- Support investigation of non-conformity reports (NCR) and product complaints by reviewing drawings and specifications.
- Comply with appropriate regulatory agencies (i.e. GMP, ISO 13485, FDA, MDR, etc.) and associated quality systems described in PMT's documentation.
- Organize and maintain CAD file structure, templates and drawing libraries.
- Other duties and responsibilities as required. Duties, responsibilities and activities may change at any time with or without notice.
QUALIFICATIONS:
- 2 yr degree or certificate in drafting, CAD design, engineering technology or related field; equivalent experience considered.
- Minimum 2 years 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.
- Familiarity with FDA, ISO 13485 and GMP documentation requirements preferred.
- Ability to read and interpret engineering sketches, specifications and manufacturing processes (machining, molding, etc.).
- Strong attention to detail, accuracy and organization.
- Good written and verbal communication skills.
- Strong personal computer skills, including SolidWorks, AutoCAD DraftSight (preferred), and Microsoft software; Word, Outlook, Excel, etc.
- Certified SolidWorks Associate (CSWA) or Professional (CSWP) a plus.
PMT is an Equal Opportunity Employer