Human Factors Engineer Sr I

Arthrex

United States

Remote

USD 110,000 - 170,000

Full time

29 hours ago
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Benefits offered by this job

Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Flexible Spending Account
401(k) Matching
Annual Bonus
Wellness Program
Tuition Reimbursement
Paid Time Off
Employee Assistance Program

Job summary

Arthrex, Inc. is seeking a Senior Human Factors Engineer to lead usability activities for medical devices throughout design, development, and maintenance. The role focuses on evaluating interfaces, guiding design decisions, and ensuring adherence to industry standards.

You will plan and execute usability studies, coordinate with cross-functional teams, and mentor HF staff while travel to accounts and shows may be required. A BS in a relevant field and 5 years' experience are expected.

Qualifications

  • BS in a relevant field is required.
  • Minimum 5 years in human factors/usability for medical devices or regulated industry.
  • Experience with design controls, documentation, and risk management.

Responsibilities

  • Lead HF efforts within Product Design and Development for new product introductions.
  • Evaluate prototype user interfaces and recommend design improvements.
  • Develop test protocols and conduct formative and summative evaluations.
  • Coordinate HF activities to meet project timelines and budgets.
  • Travel to trade shows and accounts as needed.

Skills

FDA ISO guidelines
Orthopedic anatomy knowledge
Interactive graphical prototypes
Software/hardware UI design
Usability evaluation methods
Task analysis, PCA, URRA, uFMEA
Human factors process leadership

Education

BS in Human Factors/Ergonomics/Engineering Psychology/HCI or similar

Tools

Wireframing tools

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 Sr. 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:

  • Working knowledge of FDA and ISO Human Factors guidelines for the development of medical devices required.
  • Working knowledge of anatomy from an orthopedic standpoint preferred.
  • Experience creating Interactive Graphical prototypes (wireframes).
  • Technical knowledge in development methodologies, design, and project implementation.
  • Experience designing and validating Software and/or Hardware User Interfaces.
  • Technical knowledge in usability evaluation methodologies, task analysis, PCA analysis, and heuristic assessments.
  • Technical knowledge in human information processing, sensation and perception, and ergonomics.

Education/ Experience:

  • Bachelor of Science degree in Human Factors, Ergonomics, Engineering Psychology, Experimental Psychology, Human-Computer Interaction, or similar required.
  • 5 years human factors / usability experience in a medical device or other highly regulated industry required.
  • 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
  • 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.

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