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

Arthrex; Naples (FL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Company-Provided Life Insurance

Flexible Spending Account (FSA)

401(k) Matching</name>

Annual Bonus

Paid Time Off

Onsite Medical Clinic

Free Onsite Lunch

Tuition Reimbursement

Job summary

Arthrex, Inc. in Naples, FL, seeks a Engineer, Sr. I – Product Development to lead knee and hip arthroscopy implant and instrumentation projects from concept to commercialization.

You will collaborate with surgeons, product managers, and cross-functional teams to gather user needs and deliver innovative designs. Responsibilities include design optimization, prototyping, validation, and maintaining the Design History File, with regulatory support and travel as needed.

Qualifications

• 5 years of relevant work experience required.
• Knowledge of FDA and ISO guidelines for medical devices.
• Strong understanding of orthopedic surgery principles and products.

Responsibilities

• Designs components or systems and refines existing designs for manufacturing.
• Manages project budgets and timelines.
• Leads cross-functional teams through feasibility, initiation, and execution.
• Maintains Design History File per Arthrex procedures.
• Provides regulatory support and collaborates with Marketing/PM for training.

Skills

Project management

Communication

Orthopedic product development

Anatomy knowledge

Presentation skills

Cross-functional collaboration

Education

5 years relevant work experience

Tools

SolidWorks

Creo

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.