Senior Design Engineer

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.