|Description Main Objective:
Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, and product maintenance. Project assignments shall be concentrated within the area of shoulder arthroplasty.
Essential Duties and Responsibilities:
1. Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
2. Recommends alterations to development and design to improve quality of products and/or procedures.
3. Determines budgets and timelines for assigned projects.
4. 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.
5. Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
6. Provides Regulatory department technical support for assigned projects as needed.
7. Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
8. Supports Manufacturing vendors to provide processing improvements.
9. Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
10. Determines necessity of testing and initiates testing of assigned products
11. Reports progress and status of assigned projects on a timely basis with to Engineering Manager.
12. Regularly required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
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.
Requirements Education and Experience:
Bachelor's degree required; preferably in Mechanical or Biomedical Engineering.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
? Working knowledge of anatomy from an orthopedic standpoint.
? Manufacturing process knowledge preferred.
? Knowledgeable of FDA and ISO guidelines for the development of medical devices
? Project management and communication skills training preferred.
Machine, Tools, and/or Equipment Skills:
Knowledge of surgical equipment and instrumentation, mechanical testing equipment, PC, ProEngineer or other 3D modeling software required.
State or Province