Senior Design Engineer

Alphatec Spine • Carlsbad, CA

1d

About The Position

Under routine supervision, primarily responsible for the development of new products and/or the enhancement of existing products. Lead or serve as a member of a project team. Involved in creating designs, modeling and drafting utilizing a 3D CAD system. Other responsibilities include assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project.

Requirements

• Experience with 3D CAD system, preferably Solidworks
• Experience with phase gate design control processes
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics
• Knowledge in the use and interpretation of geometric dimensioning and tolerancing
• 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
• 3-5 years of product development experience, preferably in spine or implantable orthopedic medical devices.
• Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Responsibilities

• Designs, develops and processes implants and instruments utilizing Solidworks CAD software.
• Leads the development of new products and manufacturing processes and/or serves as a member of a project team.
• Directs the development of working prototype models to be used for project design evaluation.
• Manage designers or coops
• Generates protocols for testing and analyzing new and current products.
• Generates design assurance documentation for the project Design History File (DHF).
• Develops quality control procedures and inspection methods
• Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors
• Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch.
• Provides technical input to marketing counterparts on the development of collateral marketing materials
• Provides technical expertise to marketing and sales as to intent of design function.
• Provides technical experience to Regulatory Affairs to support FDA 510K submissions.
• Creates and processes Engineering Change Orders (ECO’s)
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior