Sr. Engineer I (Mechanical) - Product Development - I&R

Arthrex•Pelican Bay, FL

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 I (Mechanical) – Product Development to support the Imaging and Resection team. This individual will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Complete understanding and application of principles, concepts, practices, and standards.
Full knowledge of industry practices.
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Technical knowledge in development methodologies, design, and project implementation.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
Ability to verbally communicate ideas and issues effectively to other team members and management.
Ability to write and record data and information as required by procedures.
5 years of relevant work experience excluding academic coursework or internships required.
Bachelor’s degree in Mechanical or Electrical Engineering required.

Nice To Haves

Manufacturing process knowledge preferred.
Project management and communication skills training preferred.
Working knowledge of anatomy from an orthopedic standpoint preferred.
Working knowledge of joint anatomy preferred.
Proficiency in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience preferable.
Knowledge of orthopedic surgery principles, theories, and products preferred.
Historical perspective on orthopedic surgery principals, theories, and products preferred.

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.