Human Factors Engineer I

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

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Paid Time Off

Tuition Reimbursement Program

Paid Parental Leave

Employee Assistance Program (EAP)

Job summary

Arthrex, Inc. is a global medical device company, and the Digital Innovation team seeks a Human Factors Engineer I to drive usability from concept through product retirement.

The role emphasizes design according to industry standards, usability testing, and collaboration with design, marketing, and other disciplines to ensure patient safety and product quality. The ideal candidate has a Bachelor of Science in Engineering, with human factors or usability experience, and a background in regulated

Qualifications

• Bachelor's degree in Engineering required.
• Human factors/usability experience preferred.
• Experience in a medical device or other highly regulated industry preferred.

Responsibilities

• Lead Human Factors efforts within Product Design and Development for new product introduction with emphasis on design according to Industry standards.
• Recommend alterations to development and design to improve Human Factors quality.
• Manage budgets and timelines for assigned projects.
• Provide leadership in understanding and implementing industry standards and design guidance.
• May supervise or coordinate the Human Factors Team as needed.
• Lead Usability Assessment activities (Task Analysis, PCA, URRA, uFMEA, Formative and Summative Evaluations).
• Drive product development, modification and improvement based on analysis.
• Support Marketing and Product Management with technical information for training and marketing.
• Prepare test protocols for Simulated Use Evaluations.
• Facilitate planning, execution, and review of Human Factors activities.
• Report progress on projects timely.

Skills

FDA/ISO guidelines

Anatomy knowledge

3D-CAD prototypes

Wireframes / interactive prototypes

Education

Bachelor of Science in Engineering

Human factors/usability experience

Medical device industry experience

Tools

Pro/E/Creo

SolidWorks

3D CAD software

Job description

Requisition ID: 67135 Title: Human Factors Engineer I

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Digital Innovation team at Arthrex is growing and we are actively searching for a Human Factors Engineer I. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective

Responsible for User Interface test and development of medical devices, during product initiation, design, development, execution, and product maintenance.

Essential Duties And Responsibilities

• Lead Human Factors efforts within Product Design and Development for new product introduction with an emphasis in design according to Industry and derived standards, evaluation of prototype user interfaces, as appropriate for the specific area of focus.


• Recommends alterations to development and design to improve the quality of Human Factors in products and/or procedures.


• Determines budgets and timelines for assigned projects.


• Provide active leadership in understanding and implementing industry standards and design guidance, acting as a resource to other disciplines within the Product Design Process, from Concept through Product Retirement, adhering closely to project timeline and budget.


• May supervise, assign and/or coordinate the work of others within the Human Factors Team to ensure design projects meet the appropriate goals.


• Lead Usability Assessment activities such as a Task Analysis, PCA Analysis, URRA Analysis, uFMEA, Formative and Summative Evaluations. Report results in appropriate documentation, adhering to Arthrex Design Control Procedures.


• Drive Product Development, Modification and/or Improvement based on analysis and/or evaluation results.


• Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.


• Prepares and develops Test Protocols describing the Objectives, Methods and Data Analysis Methods proposed for Simulated Use Evaluations of assigned projects.


• Facilitate the Planning, Execution, and Review of Human Factors activities including assessment of adequate inputs and dependencies to the Human Factors process.


• 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

• Knowledgeable of FDA and ISO Human Factors guidelines for the development of medical devices a plus.


• Working knowledge of anatomy from an orthopedic standpoint preferable.


• Experience in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience preferable.


• Experience creating Interactive Graphical prototypes (wireframes) preferable.

Education/ Experience

• Bachelor of Science degree in Engineering is required.


• Human factors / usability experience is preferred.


• Experience in a medical device or other highly regulated industry preferred.

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.