- Bachelor's degree
- Bachelor of Science
- FDA regulations
- Anatomy knowledge
- Communication skills
- Project management
Main Objective: Responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance.
Essential Duties and Responsibilities:
Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
Recommends alterations to development and design to improve quality of products and/or procedures.
Determines budgets and timelines for assigned projects.
Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
Provides Regulatory department technical support for assigned projects as needed.
Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
Supports Manufacturing to provide processing improvements.
Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
Determines necessity of testing and initiates testing of assigned products
Reports progress and status of assigned projects on a timely basis.
May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
Bachelor of Science Degree in Engineering is required. Biomedical Engineering is preferred.
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Manufacturing process knowledge preferred.
Project management and communication skills training preferred.
Working knowledge of anatomy from an orthopedic standpoint preferred.
Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.
Solves routine problems of limited scope and complexity following established policies and procedures.
Work is closely supervised. Follows specific, detailed instructions.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Naples