Role Summary:
We're seeking a Senior Mechanical Drafter with PDM administration experience to create and maintain high-quality CAD models and manufacturing documentation for regulated medical device products. This role is hands-on in SolidWorks, heavy in GD&T, and closely partnered with Engineering, Quality, Manufacturing, and external vendors. Success requires excellent communication, time management, and ownership, including disciplined document/revision control, strong follow-through, and the ability to support multiple concurrent priorities.
Key Responsibilities
Drafting / CAD Documentation
- Create and maintain SolidWorks part/assembly models and 2D drawings (components, sub-assemblies, top-level).
- Apply and interpret GD&T per ASME Y14.5 (and/or ISO GPS) to support functional requirements and manufacturability.
- Produce complete drawing packages including dimensions/tolerances, notes, surface finish, materials, assembly details, and BOMs.
- Generate inspection/FAI-ready documentation and identify CTQ features.
- Specify and document materials and manufacturing requirements with medical-device considerations (cleanliness, corrosion, sterilization compatibility, etc.).
- Document required post-processing steps (e.g., deburr, passivation, anodize, electropolish, heat treat, coatings, cleaning, marking/laser etch, additive post-processing as applicable).
Inspection / Metrology Collaboration
- Partner with Quality/Inspection to support measurement strategy (datum schemes, gaging concepts, CMM/optical measurement considerations).
- Drive resolution of drawing/inspection discrepancies with clear documentation and cross-functional alignment.
Document & Revision Control (Must-Have)
- Own drawing/configuration accuracy and ensure disciplined Document/Revision Control.
- Execute ECO/ECN changes, redlines, revision histories, and configuration control using PDM/PLM tools.
- Ensure the correct released revision is used internally and externally (manufacturing/suppliers).
Purchasing + External Vendor Coordination
- Support purchasing activities for prototypes, tooling, and outsourced fabrication/finishing as needed.
- Communicate directly with external vendors/suppliers to request quotes (RFQs), clarify requirements, coordinate lead times, and resolve print/model questions.
- Track vendor deliverables and proactively escalate risks to schedule, cost, quality, or scope.
PDM Administrator (Component Library Ownership)
- Serve as PDM Admin for SolidWorks PDM (or similar), helping maintain the system to support engineering release and collaboration.
- Maintain and govern the approved component library (standard hardware, purchased parts, common subcomponents):
- Ensure accurate metadata, part numbering, configurations, descriptions, and lifecycle states
- Prevent duplicates, drive standardization, and improve reuse
- Maintain templates and referenced models/drawings for consistent releases
- Support vault structure, workflows, permissions (as applicable), and user best practices/training in partnership with Engineering/IT.
Drafting Standards (Organizational Owner)
- Develop, maintain, and enforce organizational drafting standards including:
- Drawing templates, title blocks, revision blocks, notes, and general practices
- GD&T conventions, datum strategy guidelines, and inspection drawing expectations
- Line fonts, layers, formatting, and release requirements
- Audit drawings for compliance and lead continuous improvement of documentation quality and consistency across teams.
Soft Skills / Operational Excellence (Emphasis)
- Manage multiple priorities with strong time management and predictable execution.
- Communicate clearly and professionally (written and verbal) with internal stakeholders and vendors.
- Demonstrate ownership: close loops, keep stakeholders informed, and flag risks early.
- Mentor junior drafters and elevate drafting quality across the organization.
Required Qualifications
- 7+ years mechanical drafting experience, preferably in medical devices or another regulated industry.
- Advanced proficiency in SolidWorks (parts, assemblies, drawings, configurations).
- Strong working knowledge of GD&T and tolerance practices.
- Practical experience supporting inspection/metrology needs (datums, measurement methods, inspection readiness).
- Working knowledge of materials and manufacturing processes plus finishing/post-processing.
- Document/Revision Control experience is required (ECO/ECN process, controlled releases, configuration management).
- Experience working with PDM/PLM systems; ability to maintain structured data and drive standardization.
- Strong organizational skills and the ability to manage vendor interactions with professionalism and clarity.
Preferred Qualifications
- SolidWorks PDM Admin experience (vault/workflow governance, templates, lifecycle states, permissions).
- Experience in ISO 13485 and/or FDA 21 CFR 820 environments (DHF/DMR familiarity a plus).
- Experience ordering prototypes/tooling, RFQs, and supplier coordination for build readiness.
