Sr. Engineer I - Product Development - Knee/Hip Arthroscopy

Arthrex•Pelican Bay, FL

26d•Onsite

About The Position

Arthrex, Inc. is seeking an Engineer, Sr. I – Product Development to support the Knee and Hip Arthroscopy team at its headquarters in Naples, Florida. The role is responsible for the full life cycle development and maintenance of medical devices, from initiation and design through development and execution. The engineer leads orthopedic implant and instrumentation projects from concept through commercialization, working closely with surgeons and product managers to gather user needs and develop design solutions. The position leads multiple fast-paced projects and oversees prototyping, validation, regulatory submissions, design history file documentation, and cross-functional collaboration to meet quality and regulatory standards. The successful candidate serves as a technical subject matter expert and contributes both hands-on design work and project leadership. Travel to trade shows and customer accounts may be required, including international travel.

Requirements

At least 5 years of relevant work experience, excluding academic coursework and internships.
Bachelor’s degree in engineering.
Knowledge of FDA and ISO guidelines for medical device development.
Complete understanding and application of relevant principles, concepts, practices, and standards.
Full knowledge of industry practices.
Technical knowledge of development methodologies, design, and project implementation.
Proficiency in designing products using a 3D-CAD program.

Nice To Haves

Manufacturing process knowledge.
Training in project management and communication skills.
Working knowledge of anatomy from an orthopedic standpoint and of joint anatomy.
Experience with SolidWorks and/or Creo.
Knowledge of orthopedic surgery principles, theories, and products, including a historical perspective.

Responsibilities

Design components or functional systems and modify existing designs to develop or improve products and facilitate manufacturing operations.
Recommend development and design alterations to improve product or procedural quality.
Determine budgets and timelines for assigned projects.
Lead multifunctional new-product project teams through technical feasibility analysis, initiation, planning, execution, and termination, adhering to project timelines and budgets.
Maintain design history files for assigned projects in accordance with Arthrex design control procedures.
Provide technical support to the Regulatory department for assigned projects as needed.
Support Marketing and Product Management with technical information for product training and marketing.
Support Manufacturing with processing improvements.
Train or educate surgeon and distributor customers on technical aspects of assigned products as needed.
Determine testing needs and initiate testing of assigned products.
Report assigned project progress and status in a timely manner.
Travel to trade shows and visit established and prospective accounts as required; international travel may be required.