Senior Design Engineer

Under routine supervision, primarily responsible for the development of new products and 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. Assist in development processes for Manufacturing, Quality Control, Regulatory, and Planning.

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 for project design evaluation.
• Manages designers or co-ops.
• 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 regarding design intent and function.
• Provides technical experience to Regulatory Affairs to support FDA 510K submissions.
• Creates and processes Engineering Change Orders (ECOs).
• Other duties as assigned.

Requirements

• Experience with a 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.

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). 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.

Pay

$85,000 - $95,000 full-time annual salary.