Sr. Engineer I - Product Development - Spine

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

Job summary

A global medical device company is looking for a Sr. Engineer I in Product Development for their Spine team. Responsibilities include overseeing full life cycle development of medical devices, leading project teams, and ensuring design quality. Candidates should have a Bachelor’s degree in Engineering and a minimum of 5 years of relevant experience, alongside knowledge in FDA and ISO guidelines. This role offers the opportunity to work in a dynamic environment aimed at enhancing surgical solutions.

Qualifications

• 5 years of relevant work experience required.
• Understanding of orthopedic surgery principles preferred.
• Technical knowledge in development methodologies and design.

Responsibilities

• Lead multifunctional new product project teams through project phases.
• Designs components or functional systems for product development.
• Report progress on assigned projects on a timely basis.

Skills

Knowledgeable of FDA and ISO guidelines for the development of medical devices

Proficiency in designing products using a 3D-CAD program

Project management and communication skills training

Education

Bachelor’s degree in Engineering

Tools

Pro/E

SolidWorks

Job description

Sr. Engineer I - Product Development - Spine

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
• Bachelor’s degree in Engineering required

Language and Communication Skills

• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and