Human Factors Engineer I

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

Benefits offered by this job

Medical, Dental and Vision Insurance

Life Insurance

Flexible Spending Account (FSA)

401(k) Matching Retirement Plan

Annual Bonus

Tuition Reimbursement

Job summary

Arthrex, Inc. is seeking a Human Factors Engineer I to lead usability and design activities for medical devices within the Digital Innovation team. The role emphasizes adherence to FDA/ISO guidelines and collaboration across design, development, and marketing to ensure safe, effective products.

Responsibilities include planning usability studies, conducting analyses, developing test protocols, and guiding product development from concept through life cycle. Travel may be required.

Qualifications

• 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.

Responsibilities

• Lead Human Factors efforts within Product Design and Development for new product introduction with emphasis on design according to industry standards.
• 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.
• Lead Usability Assessment activities such as Task Analysis, URRA, Formative and Summative Evaluations; report results per Arthrex procedures.
• Drive Product Development based on analysis and evaluation results.
• Supports Marketing and Product Management with technical information for training and marketing of products.
• Prepares and develops Test Protocols describing Objectives, Methods and Data Analysis for Simulated Use Evaluations.
• Facilitate Planning, Execution, and Review of Human Factors activities including assessment of inputs and dependencies.
• May travel to trade shows and accounts; international travel may be required.

Skills

FDA/ISO guidelines

Orthopedic anatomy knowledge

3D-CAD (Pro/E/SolidWorks)

Interactive prototypes/wireframes

Education

Bachelor of Science in Engineering

Job description

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.
• 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.