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)
- Other duties as assigned.