Senior Design Engineer

Responsibilities

• Design, develop, and process implants and instruments using Solidworks CAD software
• Lead new product development and manufacturing processes or serve as a project team member
• Direct the development of working prototype models for design evaluation
• Manage designers or co-ops
• Generate protocols for testing and analyzing new and current products
• Create design assurance documentation for the Design History File (DHF)
• Develop quality control procedures and inspection methods
• Initiate design changes for manufacturability while maintaining critical product features
• Lead cross-functional teams from concept through product launch
• Provide technical input to marketing, sales, and regulatory affairs for FDA 510K submissions
• Create and process Engineering Change Orders (ECOs)

Requirements

• Undergraduate degree in mechanical or biomedical engineering
• 3-5 years of product development experience, preferably in spine or implantable orthopedic medical devices
• Experience with 3D CAD systems, preferably Solidworks
• Experience with phase gate design control processes
• Experience in a manufacturing environment involving metals and plastics
• Knowledge of geometric dimensioning and tolerancing (GD&T)
• Strong verbal and written communication skills

About the Company

Alphatec Spine, Inc. is a medical device company focused on the development of advanced spinal technologies.