Engineer, Sr. II - Product Development - Arthroplasty

NBSTSA; Naples (FL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Life Insurance

401(k) Matching

Annual Bonus

Onsite Wellness Clinics

Job summary

Arthrex, Inc. in Naples, FL is seeking a Senior Engineer II in Product Development for Arthroplasty. You will manage full lifecycle medical device development, ensure compliance with FDA/ISO guidelines, and work with cross-functional teams to bring innovative implant designs to market.

Required: Bachelor's in Engineering and 8 years of experience in orthopedic implant design, plus proficiency in 3D CAD (Creo/SolidWorks). Travel may be involved for trade shows and customer visits.

Qualifications

• Bachelor's degree in Engineering required.
• 8 years of relevant work experience required.
• Experience designing and developing orthopedic implants.
• Knowledge of FDA and ISO guidelines for medical devices.

Responsibilities

• Designs components or systems and modifies designs to improve products and manufacturing.
• Leads multifunctional new product project teams through feasibility, initiation, planning, execution, and termination.
• Maintains design history files per Arthrex procedures.
• Provides Regulatory technical support for projects as needed.
• Supports Marketing/Product Management with technical training materials.
• Travels to trade shows and accounts as required.

Skills

Orthopedic implants design

FDA/ISO guidelines knowledge

3D-CAD (Creo/SolidWorks)

Project management

Anatomy knowledge

Communication skills

Education

Bachelors degree in Engineering

Tools

Creo

SolidWorks

Job description

Engineer, Sr. II - Product Development - Arthroplasty

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 II 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. The successful candidate would have a strong understanding of FDA and ISO guidelines for the development of medical devices. Additional preferred qualifications include knowledge of manufacturing processes, training in project management and communication skills, and a working knowledge of anatomy from an orthopedic standpoint, including joint anatomy. Proficiency in designing products using a 3D-CAD program is essential. The candidate should also possess technical expertise in development methodologies, design, and project implementation, along with familiarity with orthopedic surgery principles, theories, and products. 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.

Skills:

• Experience designing and developing orthopedic implants required.
• 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. 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.

Knowledge:

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

Education/ Experience:

• Bachelors degree in Engineering required.
• 8 years of relevant work experience required.

Incidental Duties:

• The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Arthrex 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 Parental Leave
• Paid Time Off
• Volunteer PTO
• 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.