Engineer, Sr. I - Product Development - Spine

Arthrex GmbH; Naples (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Wellness Incentive Program

Tuition Reimbursement Program

Paid Time Off

Job summary

Arthrex, Inc. seeks a Sr. Engineer I – Product Development to drive full lifecycle development of spine medical devices, from concept through maintenance. You will lead design activities, coordinate with Regulatory, Marketing, and Manufacturing, and ensure compliance with design controls.

Responsibilities include project planning, testing, and collaboration with surgeons and distributors. Based in Naples, FL with possible travel to support trade shows and customer visits.

Qualifications

• Familiar with design controls and lifecycle development.
• Knowledge of FDA/ISO guidelines for medical devices.

Responsibilities

• Design components or systems and modify existing designs to improve products.
• Lead multifunctional project teams through feasibility, initiation, planning, and execution.
• Maintain design history file per Arthrex procedures.
• Provide Regulatory support for projects as needed.
• Support Manufacturing with process improvements and training for customers.

Skills

3D-CAD design

FDA/ISO knowledge

Project management

Orthopedic anatomy

Tools

Pro/E

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 the Spine team. 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 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. Pro/E 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.

Education/ Experience:

• 5 years of relevant work experience
• 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)
• Deferred Compensation Plan (DCP)

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.