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

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 and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Engineer, Sr. I – Product Development to support the Knee and Hip Arthroscopy team. This individual will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. The successful candidate will lead orthopedic implant and instrumentation projects from concept through commercialization, partnering closely with surgeons and product managers to gather user needs, develop innovative design solutions, and serve as a technical subject matter expert. This role involves managing multiple fast-paced projects, overseeing prototyping, validation, regulatory submissions, DHF documentation, and collaboration across cross‑functional teams to ensure compliance with quality and regulatory standards. Candidates should bring orthopedic product development experience, strong presentation and project leadership skills, and a passion for both hands‑on design work and bringing new products to market. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This role will be located at our headquarters in Naples, FL.

Essential Duties and Responsibilities:

• Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
• 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.
• May be required travel to attend trade shows and visit established accounts as well as prospective accounts.
• International travel may be required.

Knowledge:

• Complete understanding and application of principles, concepts, practices, and standards.
• Full knowledge of industry practices.

Skills:

• Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of anatomy from an orthopedic standpoint preferred.
• Working knowledge of joint anatomy preferred.
• Proficiency in designing products using a 3D-CAD program. SolidWorks and/or Creo experience preferable.
• Technical knowledge in development methodologies, design, and project implementation.
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Historical perspective on orthopedic surgery principals, theories, and products preferred.

Education/ Experience:

• 5 years of relevant work experience excluding academic coursework or internships required.
• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.