Engineer II - Product Development - Soft Tissue

Arthrex GmbH; Naples (FL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

401(k) retirement plan

Annual bonus

Tuition reimbursement

Paid time off

Wellness incentive program

Onsite medical clinics

Job summary

Arthrex, Inc. is seeking an Engineer II to support the Foot, Ankle & Trauma team with a primary focus on Soft Tissue product development.

You will lead full lifecycle development of medical devices, from initiation to maintenance, while collaborating with Regulatory, Marketing, and Manufacturing to drive successful outcomes. The role requires a Bachelor's degree in Engineering and at least 2 years of relevant experience, along with strong project management and communication skills in a medical

Qualifications

• Bachelor's degree in Engineering is required.
• Minimum of 2 years of relevant experience outside academic coursework and internships.
• Strong communication and project management skills are preferred.
• Familiarity with medical device development and design controls is advantageous.

Responsibilities

• Lead cross-functional new product projects from feasibility to closure within time and budget.
• Maintain design history file according to Arthrex design control procedures.
• Provide regulatory technical support for assigned projects as needed.
• Support Marketing and Product Management with technical information for training and marketing.
• Assist Manufacturing with processing improvements and efficiency.
• Travel to trade shows and accounts as needed; international travel may be required.

Skills

FDA/ISO guidelines

Manufacturing knowledge

Project management

Anatomy knowledge (orthopedic)

Education

Bachelor's degree in Engineering

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 an Engineer II to support the Foot, Ankle & Trauma team, with a primary focus on Soft Tissue product development and related initiatives. 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:

• Frequent use and general knowledge of industry practices, techniques, and standards.
• General application of concepts and principles.

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.
• 2 years of experience required outside of academic coursework and internships.
• 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.