Human Factors Engineering - Associate Engineering Fellow

Takeda Pharmaceutical Company-posted 4 months ago
$153,600 - $241,340/Yr
Full-time • Senior
Lexington, MA
5,001-10,000 employees
Chemical Manufacturing
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Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF) is responsible for Human Centered Design of Medical Devices and Combination Products. The HFE Lead - AEF will be integral to design and development of product user interface including hardware, software, packaging, labeling, and instruction material to support safe and effective use of the product for the intended use by the intended users in the anticipated use environment.

  • Leading and executing Human Factors strategy in compliance with regional regulatory guidance.
  • Driving and overseeing User Research strategy in compliance with Quality Management System.
  • Developing Human Factors Product and System level requirements in alignment with Target Product Profile.
  • Conducting exploratory research to gather user insights and design trends and evaluate user interface concepts.
  • Translating user needs into user experience and interface requirements and specifications.
  • Designing and executing Human Factors studies to iteratively evaluate product user interface - including hardware, software, packaging, instructional material, and training.
  • Conducting Task and Known Use Problem Analyses.
  • Performing use-safety engineering through Use-related Risk Analysis.
  • Developing Human Factors Validation Protocols and Reports.
  • Managing Human Factors, Industrial Design, and User Research vendors.
  • Supporting regulatory Human Factors Information Requests.
  • Developing Human Factors Summary Reports in compliance with FDA guidance.
  • Developing Usability Engineering Files in compliance with IEC and ISO standards.
  • Leading development to Human Factors standard operating procedures and templates development.
  • Applying functional knowledge of applicable guidance, regulations, standards, and industry best practices to medical device and combination product design and development process.
  • Preparing documentation to support medical device and combination product development activities including design controls.
  • Collaborating with cross functional team members from mechanical, software, clinical, regulatory, and quality engineering disciplines.
  • Qualifying and managing Human Factors vendors.
  • Supporting internal and external quality audits.
  • Communicating with internal and external key stakeholders.
  • Mentoring Human Factors Engineering Leads.
  • Doctorate degree and 10+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
  • OR, Master's degree and 13+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
  • OR, Bachelor's degree and 15+ years of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
  • Good physical health is essential for visiting manufacturing sites or conducting user testing in clinical environments.
  • Medical, dental, vision insurance
  • 401(k) plan and company match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Tuition reimbursement program
  • Paid volunteer time off
  • Company holidays
  • Well-being benefits
  • Up to 80 hours of sick time per calendar year
  • Up to 120 hours of paid vacation for new hires
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