Cad Engineer

Key Responsibilities:

• Create and update 2D and 3D CAD models and engineering drawings using SolidWorks.
• Maintain accurate CAD databases and revision-controlled design files in accordance with Quality Management System (QMS) protocols.
• Generate and maintain Bill of Materials (BOMs) for all products and design configurations.
• Support the Design History File (DHF) compilation by providing up-to-date drawings, BOMs, and release records.
• Ensure proper version control, file storage, and change documentation in alignment with document control procedures.
• Process Engineering Change Requests (ECRs) and execute Engineering Change Orders (ECOs) with appropriate drawing updates.
• Participate in design reviews, perform CAD documentation updates, and review drawing checklists for accuracy and completeness.
• Maintain traceability of design records across design input, output, verification, and validation stages.
• Collaborate with Quality Assurance (QA) to ensure all CAD deliverables meet internal standards and regulatory requirements (ISO 13485, FDA 21 CFR Part 820).
• Provide necessary design documentation and CAD records during internal and external audits.
• Support prototype and production teams by delivering precise and manufacturable CAD files and drawings.
• Communicate cross-functionally with R&D, QA, Manufacturing, and Regulatory teams.

Required Qualifications:

• Diploma/Degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 3+ years of experience in a CAD engineering role within a medical device or precision engineering company; orthopedic implant experience preferred.
• Expertise in SolidWorks and AutoCAD (3D modeling, assemblies, drafting, GD&T, drawing templates, etc.).
• Strong knowledge of engineering drawing standards (ASME Y14.5, ISO) and tolerancing practices.
• Familiarity with PLM/PDM systems and CAD data management tools.
• Understanding of Design Control principles, DHF documentation, and regulatory requirements for Class II/III medical devices.
• Hands-on experience with ECR/ECO processes and BOM management.
• Knowledge of manufacturing processes, particularly CNC machining, casting, and surface treatments relevant to orthopedic implants.
• Proficient in drawing review, revision tracking, and model history documentation.
• Detail-oriented, with strong analytical and organizational skills.
• Ability to work both independently and in a team-oriented environment.

Nice to have hands on:

• Experience with Additive Manufacturing and FEA simulations is a plus.
• Familiarity with ISO 13485, FDA Design Control regulations, and CE/USFDA design documentation standards.
• Experience supporting audit processes (Notified Body, FDA, Internal) from a CAD/documentation perspective.

Key Tools & Documents:

• SolidWorks, AutoCAD (2D/3D Modeling)
• Drawing Review Checklists
• Engineering Change Requests (ECRs) & Engineering Change Orders (ECOs)
• Bill of Materials (BOMs)
• DHF Drawing Contribution Records
• CAD Model Revision Logs
• Verification and Validation Evidence
• Document Control Systems (PDM/PLM)