Design Engineer

About the role

Under routine supervision, primarily responsible for the enhancement of existing products on our sustaining team. Involved in creating concepts and modeling and drafting designs utilizing 3D CAD software.

Responsibilities

• Designs and develops implants and instruments utilizing SolidWorks.
• Affords assistance in the development of new products and manufacturing processes, or serves as a member of a development team.
• Assists in the creation of working models 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.
• Affords technical input to marketing counterparts on the development of collateral marketing materials.
• Affords technical expertise to Marketing and Sales as to intent of design function.
• Affords technical expertise to Regulatory Affairs to support FDA 510(k) submissions and/or international registrations.
• Creates and processes Change Orders (CO's).

Requirements

• Experience with 3D CAD software, preferably SolidWorks.
• Strong verbal and written communication skills; comfortable presenting to senior management.
• Knowledge in the use and interpretation of geometric dimensioning and tolerancing, preferred.
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics, preferred.

Qualifications

• 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.