Sr. Engineer I - Product Development - Arthroplasty

Arthrex GmbH; Naples (FL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Matching Plan

Annual Bonus

Tuition Reimbursement Program

Free Onsite Lunch

Paid Time Off

Job summary

Arthrex GmbH is looking for a Sr. Engineer I – Product Development in Naples, Florida. The successful candidate will handle the full life cycle development of medical devices, including design, development, and execution, while ensuring adherence to quality standards. Responsibilities include leading product project teams, maintaining design history files, and providing technical support for marketing and regulatory purposes. Candidates need 5 years of relevant experience and proficiency in 3D-CAD programs like Creo or SolidWorks. The role offers comprehensive benefits including health insurance and a 401(k) matching plan.

Responsibilities

• Design components or functional systems and improve products.
• Determine budgets and timelines for projects.
• Lead multifunctional new product project teams.
• Maintain design history files adhering to procedures.
• Provide technical support for regulatory projects.
• Support marketing with technical information.

Skills

FDA and ISO guidelines knowledge

Manufacturing process knowledge

Project management skills

Communication skills

3D-CAD proficiency

Technical knowledge in development methodologies

Orthopedic surgery principles knowledge

QMS experience

Arthroplasty experience

Education

5 years of relevant work experience

Tools

Creo

SolidWorks

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 Sr. Engineer I – Product Development to support various projects within Arthroplasty. This individual will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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 preferred.
• 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. Creo and/or SolidWorks 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.
• QMS experience preferred.
• Arthroplasty experience preferred.

Education/ Experience:

• 5 years of relevant work experience excluding academic coursework or internships required.

Benefits:

• 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.