Design Engineer in Carlsbad

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. Other responsibilities include drafting of design history file documents, development of test plans to assess designs, and assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project., * 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.

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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,
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics, .

Education and Experience

• 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., At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $75,000 to $90,000 Full-Time Annual Salary