Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)
Takeda
June 24, 2026
Remote friendly (Lexington, MA)
United States
$154,400 - $242,550 USD yearly
Operations
Objective
Human Factors Engineering (HFE) Lead – Associate Engineering Fellow (AEF) responsible for human-centered design of medical devices and combination products, including user interface (hardware, software, packaging, labeling, and instruction materials) to support safe and effective use.
Responsibilities
- Lead and execute Human Factors strategy per regional regulatory guidance.
- Drive User Research strategy per Quality Management System.
- Develop HFE product and system requirements aligned to Target Product Profile.
- Conduct exploratory and AI-augmented research (digital ethnography, remote usability platforms, synthetic user simulations).
- Translate user needs into UX and interface requirements/specifications.
- Design and execute Human Factors studies to iteratively evaluate user interfaces.
- Perform use-safety engineering with data-driven risk management (predictive modeling, AI-assisted signal detection).
- Develop and manage Human Factors validation protocols and reports.
- Manage Human Factors and user research/design vendors.
- Create and implement Human Factors regulatory strategies.
- Develop Usability Engineering Files per IEC and ISO standards.
- Lead development of HFE SOPs and templates.
- Apply guidance/regulations/standards and industry best practices; prepare design-control documentation.
- Partner cross-functionally and mentor HFE leads.
- Support quality audits; communicate with key stakeholders.
Qualifications
- Doctorate + 7+ years, or Master’s + 13+ years, or Bachelor’s + 15+ years in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, or related device/biotech design degrees.
Travel
- Up to 20% yearly travel.
Benefits
- U.S. employees may be eligible for medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Human Factors Engineering (HFE) Lead – Associate Engineering Fellow (AEF) responsible for human-centered design of medical devices and combination products, including user interface (hardware, software, packaging, labeling, and instruction materials) to support safe and effective use.
Responsibilities
- Lead and execute Human Factors strategy per regional regulatory guidance.
- Drive User Research strategy per Quality Management System.
- Develop HFE product and system requirements aligned to Target Product Profile.
- Conduct exploratory and AI-augmented research (digital ethnography, remote usability platforms, synthetic user simulations).
- Translate user needs into UX and interface requirements/specifications.
- Design and execute Human Factors studies to iteratively evaluate user interfaces.
- Perform use-safety engineering with data-driven risk management (predictive modeling, AI-assisted signal detection).
- Develop and manage Human Factors validation protocols and reports.
- Manage Human Factors and user research/design vendors.
- Create and implement Human Factors regulatory strategies.
- Develop Usability Engineering Files per IEC and ISO standards.
- Lead development of HFE SOPs and templates.
- Apply guidance/regulations/standards and industry best practices; prepare design-control documentation.
- Partner cross-functionally and mentor HFE leads.
- Support quality audits; communicate with key stakeholders.
Qualifications
- Doctorate + 7+ years, or Master’s + 13+ years, or Bachelor’s + 15+ years in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, or related device/biotech design degrees.
Travel
- Up to 20% yearly travel.
Benefits
- U.S. employees may be eligible for medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.