Human Factors Engineering (HFE) Lead - Associate Engineering Fellow (AEF)
Takeda
August 07, 2026
On-site
Lexington, MA
$154,400 - $242,550 USD yearly
Other
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Objective
- Lead Human Centered Design for medical devices/combination products, including user interface (hardware, software, packaging, labeling, instruction) to support safe/effective use. Advance AI-enabled HFE capabilities by prioritizing high-impact digital transformation initiatives.
Responsibilities
- Lead and execute Human Factors strategy per regional regulatory guidance.
- Drive user research strategy per Quality Management System.
- Develop product/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/interface requirements and specifications.
- Design and execute Human Factors studies for iterative UI evaluation (hardware/software/packaging/instruction/training).
- Perform use-safety engineering and data-driven risk management (predictive modeling, AI-assisted signal detection).
- Develop/manage Validation Protocols and Reports; manage HFE/design/user research vendors.
- Create Human Factors regulatory strategies; develop Usability Engineering Files (IEC/ISO).
- Develop HFE SOPs/templates; apply relevant guidance/standards best practices; prepare design-control documentation.
- Partner cross-functionally; support audits; communicate with stakeholders; mentor HFE leads.
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.
Requirements
- Travel up to 20% yearly (domestic/international); occasional site visits/user testing may involve standing/walking.
Compensation & Benefits (U.S.)
- Base salary range: $154,400–$242,550.
- May include incentives and benefits such as medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, PTO, holidays, and well-being benefits.
Objective
- Lead Human Centered Design for medical devices/combination products, including user interface (hardware, software, packaging, labeling, instruction) to support safe/effective use. Advance AI-enabled HFE capabilities by prioritizing high-impact digital transformation initiatives.
Responsibilities
- Lead and execute Human Factors strategy per regional regulatory guidance.
- Drive user research strategy per Quality Management System.
- Develop product/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/interface requirements and specifications.
- Design and execute Human Factors studies for iterative UI evaluation (hardware/software/packaging/instruction/training).
- Perform use-safety engineering and data-driven risk management (predictive modeling, AI-assisted signal detection).
- Develop/manage Validation Protocols and Reports; manage HFE/design/user research vendors.
- Create Human Factors regulatory strategies; develop Usability Engineering Files (IEC/ISO).
- Develop HFE SOPs/templates; apply relevant guidance/standards best practices; prepare design-control documentation.
- Partner cross-functionally; support audits; communicate with stakeholders; mentor HFE leads.
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.
Requirements
- Travel up to 20% yearly (domestic/international); occasional site visits/user testing may involve standing/walking.
Compensation & Benefits (U.S.)
- Base salary range: $154,400–$242,550.
- May include incentives and benefits such as medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, PTO, holidays, and well-being benefits.