Design Engineer at ATEC Spine in Carlsbad, CA

Summary: ATEC Spine is a company focused on enhancing existing products in the medical device sector. The Design Engineer will be responsible for creating concepts, modeling, and drafting designs using 3D CAD software, while also supporting various development processes across manufacturing and regulatory affairs. Responsibilities: - Designs and develops implants and instruments utilizing SolidWorks - Assists in the development of new products and manufacturing processes and/or serves as a member of a development team - Assists in the development of working models to be used for design evaluation - Generates protocols for testing and analyzing new and current products - Generates design assurance documentation for the project Design History File (DHF) - Collaborates on the development of inspection methods - Initiates design changes relative to manufacturability while maintaining critical features for in house manufacturing or vendors - Serves on cross-functional product development teams responsible for new product development from concept through product launch - Assists Project Engineers with providing technical input to marketing counterparts on the development of collateral marketing materials - Assists Project Engineers with providing technical expertise to Marketing and Sales as to intent of design function - Assists Project Engineers with providing technical expertise to Regulatory Affairs to support FDA 510(k) submissions and/or international registrations - Creates and processes Change Orders (CO's) - Other duties as assigned Required Qualifications: - Experience with 3D CAD software, preferably SolidWorks - Strong verbal and written communication skills; comfortable presenting to senior management - Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics - 1-4 years of product development experience, preferably in spine or implantable orthopedic medical devices - For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable) Preferred Qualifications: - Knowledge in the use and interpretation of geometric dimensioning and tolerancing - Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics Required Skills: SolidWorks, 3D CAD software Important Skills: Geometric dimensioning, Manufacturing methods Nice-to-Have Skills: Technical expertise, Project management