Alphatec Spine
Manager, Development - Advanced Technology
Alphatec Spine, Carlsbad, California, United States, 92011
Technical Manager
Looking for a hands-on technical manager to support product development by leading an engineering team focused on developing innovative technologies for the spine market. This individual will have ultimate responsibility for the execution of the team they lead, and delivery of products to market. Involved in identifying opportunities for innovation, enhancing the company's existing products and determining product end of life, while also driving deeper engagement within the engineering department towards the organization's top priorities. Additional responsibilities include identifying ways to streamline the new product development process and enhancing cross functional relations to ensure we are driving procedural efficiencies across departments. This role will be responsible for the technical and professional growth of the engineering team that they lead. This role will have direct surgeon interactions. Essential Duties and Responsibilities Independently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instruments. Develops the technical skills and directs the professional growth of an engineering team. Leads the development of new products and manufacturing processes and/or serves as a leader of a project team. Manages the development of working prototype models to be used for project design evaluation. 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.
Looking for a hands-on technical manager to support product development by leading an engineering team focused on developing innovative technologies for the spine market. This individual will have ultimate responsibility for the execution of the team they lead, and delivery of products to market. Involved in identifying opportunities for innovation, enhancing the company's existing products and determining product end of life, while also driving deeper engagement within the engineering department towards the organization's top priorities. Additional responsibilities include identifying ways to streamline the new product development process and enhancing cross functional relations to ensure we are driving procedural efficiencies across departments. This role will be responsible for the technical and professional growth of the engineering team that they lead. This role will have direct surgeon interactions. Essential Duties and Responsibilities Independently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instruments. Develops the technical skills and directs the professional growth of an engineering team. Leads the development of new products and manufacturing processes and/or serves as a leader of a project team. Manages the development of working prototype models to be used for project design evaluation. 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.