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

Arthrex•Pelican Bay, FL

26d•Onsite

About The Position

Arthrex is seeking a Senior I Product Development Engineer to support its Knee and Hip Arthroscopy team at the company headquarters in Naples, Florida. The role is responsible for the full life cycle development of medical devices, from initiation, design, and development through execution and product maintenance. The engineer leads orthopedic implant and instrumentation projects from concept through commercialization, working with surgeons and product managers to gather user needs and develop design solutions. The position also involves managing multiple projects, overseeing prototyping and validation, supporting regulatory submissions, maintaining design history file documentation, and collaborating across functions to meet quality and regulatory standards. The successful candidate brings orthopedic product development experience, presentation and project leadership skills, and an interest in hands-on design and bringing products to market. The role may require domestic and international travel to trade shows and customer accounts.

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.
Technical knowledge of development methodologies, design, and project implementation.
Complete understanding and application of relevant principles, concepts, practices, and standards, and full knowledge of industry practices.

Nice To Haves

Manufacturing process knowledge.
Training in project management and communication skills.
Working knowledge of orthopedic anatomy and joint anatomy.
Proficiency in 3D-CAD product design; SolidWorks and/or Creo experience is preferable.
Knowledge of orthopedic surgery principles, theories, and products.
Historical perspective on orthopedic surgery principles, theories, and products.

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 procedure 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 training and marketing of assigned products.
Support Manufacturing in developing 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 project progress and status in a timely manner.
Travel as needed to trade shows and established or prospective accounts; international travel may be required.