Senior Product Development Engineer of Radiofrequency Ablation

Arthrex

(Naples, Florida)
Full Time Travel Required
Job Posting Details
About Arthrex
Welcome to Arthrex we are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.
Summary
Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, and product maintenance. The projects you work on will be tailored to the specific project team you are assigned to (i.e., Knee/Hip; Distal Extremities; or Upper Extremity). Recognized as technical leader and resource.
Responsibilities
* Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations. * Supervises, assigns, and coordinates the work of engineering designers/technicians and others on projects and assignments as appropriate. * Provides expert consultation in one or more areas of design, development, and implementation of technical products or systems. * 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 to Engineering Manager. * Provides input and direction to other members of the engineering staff to assist them in their assignments and provide them with learning experience. * Up to 15% travel. **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.
Ideal Candidate
**Education and Experience:** * Minimum of a Bachelor of Science Degree in Mechanical or Biomedical Engineering required. MS preferred. Minimum of 7-10 years of relevant experience. **Knowledge and Skill Requirements/Specialized Courses and/or Training:** * Working knowledge of joint anatomy. * Proficiency in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience preferable. * Manufacturing process knowledge preferred. * Technical knowledge in development methodologies, design, and project implementation. * Knowledge of orthopedic surgery principles, theories, and products. * Historical perspective on orthopedic surgery principals, theories, and products * Working knowledge of anatomy from an orthopedic standpoint. * Knowledgeable 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:** * Knowledge of surgical equipment and instrumentation, mechanical testing equipment, PC, ProEngineer or other 3D modeling software required.

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