Senior I Engineer, Orthopedic Product Development

Arthrex; Naples (FL); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Company provided life insurance

Matching 401(k)

Annual bonus

Free onsite medical clinics

Free onsite lunch

Job summary

Arthrex, Inc. is a global medical device company focused on knee and hip arthroscopy. We seek a Sr. I – Product Development Engineer to own the full life cycle of medical devices, from concept through commercialization, partnering with surgeons and product managers to translate user needs into robust designs.

The role requires project leadership, prototyping, validation, regulatory submissions, and DHF documentation, with travel as needed. Naples, FL headquarters.

Qualifications

• 5 years of relevant experience required.
• Experience in medical device product development.
• Knowledge of FDA/ISO guidelines and design controls.

Responsibilities

• Lead orthopedic implant and instrumentation projects from concept to commercialization.
• Maintain design history file per Arthrex design control procedures.
• Provide regulatory support and collaborate with cross-functional teams.
• Train and educate surgeons, distributors on technical aspects of assigned products.
• Oversee prototyping, validation, and regulatory submissions.
• Travel to trade shows and accounts as needed.

Skills

3D-CAD design

SolidWorks/Creo

FDA/ISO guidelines

Project management

Anatomy knowledge

Orthopedic product development

Education

5 years of relevant experience

Job description

Arthrex, Inc. is a global medical device company focused on knee and hip arthroscopy. We seek a Sr. I – Product Development Engineer to own the full life cycle of medical devices, from concept through commercialization, partnering with surgeons and product managers to translate user needs into robust designs.

The role requires project leadership, prototyping, validation, regulatory submissions, and DHF documentation, with travel as needed. Naples, FL headquarters.