- Design Controls
- Time Management
- Presentation Skills
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.
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.
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.
Experience with 3D CAD system, preferably Solidworks
Experience with phase gate design control processes
Demonstrated success in leading cross-functional product development teams from concept through product launch, including demonstrated planning, organizing and time management skills
Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics
Knowledge in the use and interpretation of geometric dimensioning and tolerancing
Strong verbal and written communication skills; comfortable presenting to senior management
EDUCATION and/or EXPERIENCE
Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics
4-6 years of product development experience in implantable orthopedic medical devices, preferably in spine.