Sr. Design Engineer I - Product Development - Spine

 Requisition ID:                       63347                          Title: Sr. Design Engineer I - Product Development - Spine Division: Arthrex, Inc. (US01) Location: Naples, FL

 

 

 

 

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 Senior Design Engineer I – Product Development - Spine. This individual will be responsible for overseeing the 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™.

               

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.

 

Education/ Experience:            

• 5 Years of experience
• Bachelors degree in Engineering required (Mechanical, Biomedical, Electrical or Software Engineering) 

 

Knowledge:      

• Complete understanding and application of principles, concepts, practices, and standards. 
• Full knowledge of industry practices.

 

Discretion/Latitude:                  

• Work is performed under general direction. 
• Participates in determining objectives of assignment.  Plans schedules and arranges own activities in accomplishing objectives. 
• Work is reviewed upon completion for adequacy in meeting objectives.

 

Skills:                   

• 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.
• Working knowledge of joint anatomy preferred.
• Proficiency in designing products using a 3D-CAD program.  Pro/E and/or SolidWorks experience preferable.
• Technical knowledge in development methodologies, design, and project implementation.
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Historical perspective on orthopedic surgery principals, theories, and products preferred.

 

Language and Communication Skills:

• 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 requ