Project Engineer Knee & Hip

MAIN OBJECTIVE:Will be responsible for the full life cycle development of Orthopedic medical devices, which includes initiation, design, development, execution and implementation. In addition, must be able to coordinate activities with other departments including testing, packaging engineering, quality control, and planning.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manages numerous engineering projects of varying complexity through the design, prototype development , verification, and validation processes until successful transition of products to market.Fully understands and complies with the Quality System Regulations and Medical Device Directives, as well as internal procedures that govern design control.Responsible for product maintenance through the company’s internal change request process.Interface with manufacturers, surgeons, sales representatives, and internal Arthrex departments including testing, packaging engineering, quality control, regulatory, planning and manufacturing.Generate project schedules and milestones. Communicates this information to team leader and other departments.Develops new ideas and products from time spent at conferences, meetings and in surgery.Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.Prepares sketches, models and detailed drawing, performs necessary calculations, initiates product testing, coordinates design criteria with departments, maintains device history files, gathers information for regulatory submissions, works in the lab with surgeons.Interacts with Marketing/Sales, Reliability and Manufacturing Engineering (where appropriate) to resolve manufacturing issues associated with product design. Provide support in new product transition to Manufacturing.Interacts with vendors, where appropriate, to resolve quality and lead-time issues, and provides manufacturing improvements through implementation of new technology.
INCIDENTAL DUTIES:

(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.)

Benefits Summary:
Medical/Dental Arthrex pays 100% for employee and participates in dependent coverage
Life Insurance 25k for all employees
Longterm disability insurance All employees
401k Savings Plan Competitive 401k plan
Lunch Time Catered Lunches four days a week
Fitness Club Use of fitness cards for local gym
REQUIREMENTS
Education and Experience:
BS degree in mechanical or biomedical engineering plus experience. A minimum of 5 years of relevant medical device experience is required, preferably in the development of knee and hip orthopedic implants and instrumentation.

Knowledge and Skill Requirements:
Working knowledge of anatomy from an orthopedic standpoint. Manufacturing process knowledge preferred.

Specialized Courses and/or Training:
Knowledgable of FDA and ISO guidelines for the development of medical devices required. Project management and communication skills training preferred.

Machine, Tools and/or Equipment Skills:
Pro Engineer or other 3D modeling software required.