Principal Engineer - Product Development - DEX at Arthrex, Inc. in Naples, Florida

Job Description:

Requisition ID: 55154 Title: Principal Engineer - Product Development - DEX Division: Arthrex, Inc. (US01) Location: Naples, FL

Arthrex, Inc. is a global medical device company leader in new product development and medical education. The DEX Product Development Engineer Team is seeking a Principal Engineer at our Naples campus who will be r esponsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. This position will lead Total Ankle projects including design and development. The ideal candidate will have 12 plus years' experience in the medical device industry, preferably in orthopedics or arthroplasty, strong design and technical skills and a Bachelor's degree in Engineering. Strong CAD skills are essential. 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:

• 12 years of experience


• Bachelor's degree in Engineering required, Preferably in Mechanical, Biomedical or Electrical


• Master's degree preferred

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.


• Technical knowledge in development methodologies, design, and project implementation.


• State of the art knowledge of orthopedic surgery principles, theories, and products preferred.


• Historical perspective on orthopedic surgery principals, theories, and products preferred.

Knowledge:

Regularly contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.

Reasoning Ability:

Develops solutions to complex problems, which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives.

Discretion/ Latitude:

Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment. May supervise the activities of lower-level personnel.

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.