- Communication Skills
- Project Management
- Anatomy Knowledge
- FDA Regulations
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, specifically for textile constructs and devices
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.
3 Years of experience required.
BS Degree Engineering. Mechanical, Biomedical, Textile or Polymer Engineering preferred.
Understanding of principles of textile engineering, with preference in medical or technical textile products.
Basic knowledge of textile manufacturing processes, including braiding, weaving, knitting, and embroidery.
Familiar with product design, testing, and manufacturing of textile materials and related products.
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.
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