Human Factors Engineer II

National Society for Black Engineers; Naples (FL); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Flexible Spending Account (FSA)

401(k) Retirement Plan

Annual Bonus

Paid Time Off

Tuition Reimbursement Program

Job summary

Arthrex, Inc. seeks a Human Factors Engineer II in Naples, Florida. You will lead Human Factors efforts in the design and development of medical devices, ensuring compliance with FDA and ISO guidelines. The ideal candidate has a Bachelor of Science in Engineering, at least 2 years of usability experience, and knowledge of 3D-CAD tools like Pro/E or SolidWorks. Benefits include medical insurance, a 401(k) plan, and voluntary life insurance, among others.

Qualifications

• Minimum of 2 years of human factors/usability experience required.
• Experience in a medical device or other highly regulated industry preferred.

Responsibilities

• Lead Human Factors efforts within Product Design and Development.
• Recommends alterations to improve Human Factors quality.
• Prepares Test Protocols for Simulated Use Evaluations.

Skills

Knowledge of FDA and ISO Human Factors guidelines

3D-CAD program proficiency

Experience with Interactive Graphical prototypes

Human information processing

Usability evaluation methodologies

Education

Bachelor of Science degree in Engineering

Tools

Pro/E

SolidWorks

Job description

Requisition ID: 65767 Title: Human Factors Engineer II

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 II. 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 preferable.
• Working knowledge of anatomy from an orthopedic standpoint preferable.
• Proficiency in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience preferable.
• Experience creating Interactive Graphical prototypes (wireframes) preferable.
• Technical knowledge in human information processing, sensation and perception, and ergonomics.
• Experience designing and validating Software and/or Hardware User Interfaces.
• Experience in usability evaluation methodologies, task analysis, PCA analysis, and heuristic assessments.

Education / Experience

• Bachelor of Science degree in Engineering is required.
• Minimum of 2 years of human factors / usability experience required.
• 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.