Sr. Engineer - 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 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. Our ideal candidate would have strong knowledge of FDA and ISO guidelines for medical device development, along with technical expertise in design methodologies and project implementation.

Proficiency in 3D-CAD design (preferably Pro/E or Solid Works) is essential. Familiarity with manufacturing processes, orthopedic surgery principles, and joint anatomy is preferred, as well as a historical perspective on orthopedic theories and products. Project management and communication skills training are a plus. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• 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.

• 5 Years of relevant work experience.
• Bachelors degree in Engineering required (Mechanical, Biomedical, Electrical).

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

• 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 Solid Works 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.

• 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.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals…