Engineer I - Product Development - I&R

Arthrex; Naples (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

FSA

Supplemental Insurance Plans

401(k) Matching

Annual Bonus

Wellness Incentive Program

Onsite Medical Clinics

Onsite Lunch

Tuition Reimbursement

Parental Leave

Paid Time Off

Volunteer PTO

EAP

Job summary

Arthrex, Inc. is a global medical device company leading in orthopedics product development. We seek an Engineer I to own full life cycle development of medical devices, from initiation through maintenance, including collaboration with regulatory, marketing, and manufacturing teams.

The role requires a Bachelors degree in Engineering and involves travel as needed. Arthrex offers comprehensive benefits and ongoing professional development.

Qualifications

• Knowledge of FDA and ISO guidelines for medical devices.
• Manufacturing process knowledge is preferred.
• Project management and communication skills training is preferred.
• Working knowledge of anatomy from an orthopedic standpoint is preferred.

Responsibilities

• Design components or systems and improve products to aid manufacturing operations.
• Lead multifunctional product development teams through feasibility, initiation, planning, and execution.
• Maintain design history files and adhere to design control procedures.
• Provide regulatory support and technical information for training and marketing.

Skills

FDA/ISO guidelines

Manufacturing process knowledge

Project management training

Orthopedic anatomy knowledge

Education

Bachelors degree in Engineering

Job description

Requisition ID: 67038

Title: Engineer I - Product Development - I&R

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 an Engineer I. This individual will be responsible for the 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:

• Limited use and\/or application of basic principles, theories, and concepts.
• Limited knowledge of industry practices and standards.

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.

Education/Experience:

• Bachelors degree in Engineering required.

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.