Sr. Engineer II - Product Development - Arthroplasty

Arthrex•Pelican Bay, FL

19h

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Engineer II to support various projects within Arthroplasty. This individual will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. The successful candidate would have a strong understanding of FDA and ISO guidelines for the development of medical devices. Proficiency in designing products using a 3D-CAD program is essential. The candidate should also possess technical expertise in development methodologies, design, and project implementation, along with familiarity with orthopedic surgery principles, theories, and products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Knowledgeable of FDA and ISO guidelines for the development of medical devices.
Proficiency in designing products using a 3D-CAD program.
Technical knowledge in development methodologies, design, and project implementation.
Complete understanding and application of principles, concepts, practices, and standards.
Full knowledge of industry practices.
Bachelors degree in Engineering.
8 years of relevant work experience.

Nice To Haves

Manufacturing process knowledge.
Project management and communication skills training.
Working knowledge of anatomy from an orthopedic standpoint.
Working knowledge of joint anatomy.
Creo and/or SolidWorks experience.
Knowledge of orthopedic surgery principles, theories, and products.
Historical perspective on orthopedic surgery principals, theories, and products.

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.