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.
Essential Duties and 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)