Senior Design Engineer

The Senior Design Engineer will be primarily responsible for the development of new products and / or the enhancement of existing products. Involved in creating concepts and modeling and drafting designs utilizing 3D CAD software. Other responsibilities include drafting of design history file documents, development of test plans to assess designs, and assisting in the development of processes for Manufacturing, Quality Control, Regulatory and Planning.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Designs and develops surgical instruments utilizing SolidWorks.
• Assists in the development of new products and manufacturing processes and / or serves as a member of a development team.
• Assists in the development of working models to be used for design evaluation.
• Generates protocols for testing and analyzing new and current products.
• Generates design assurance documentation for the project Design History File (DHF).
• Collaborates on the development of inspection methods.
• Initiates and executes design changes relative to manufacturability while maintaining critical features for in house manufacturing or vendors.
• Serves on cross-functional product development teams responsible for new product development from concept through product launch.
• Assists Project Engineers with providing technical input to marketing counterparts on the development of collateral marketing materials
• Assists Project Engineers with providing technical expertise to Marketing and Sales as to intent of design function.
• Assists Project Engineers with providing technical expertise to Regulatory Affairs to support FDA 510(k) submissions and / or international registrations.
• Creates and processes Change Orders (CO’s)
• Other duties as assigned.

Requirements

The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.