AI-Enabled Human Factors Lead for Medical Devices

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); Presencial; USD 154.000 - 243.000; Jornada completa

Descripción de la vacante

Takeda in Lexington, MA is seeking an HFE Lead - Associate Engineering Fellow to drive human-centered design of medical devices and combination products, shaping product UI across hardware, software, packaging and labeling to ensure safe use.

The role leads AI-augmented human factors initiatives, develops user research, creates usability files, manages vendors, and partners with cross-functional teams, with up to 20% travel; advanced degrees and many years experience required.

Formación

• Doctorate or master's or bachelor's degree with extensive Human Factors/biomedical/industrial engineering experience in device design or biotech industry.
• Experience leading Human Factors strategy and user research within regulated medical device environments.
• Strong understanding of IEC/ISO usability engineering standards and design controls.

Responsabilidades

• Lead and execute Human Factors strategy in compliance with regulatory guidance.
• Develop and manage Human Factors Requirements and Usability Engineering Files.
• Oversee User Research and data collection, including AI-augmented methods.
• Manage Human Factors vendors and contracts, and mentor HF leads.
• Prepare regulatory documentation and support audits.

Conocimientos

Human Factors Engineering

Biomedical Engineering

Industrial Engineering

AI-enabled design

Regulatory compliance

Vendor management

Educación

Doctorate degree

Master's degree

Bachelor's degree

Descripción del empleo

Takeda in Lexington, MA is seeking an HFE Lead - Associate Engineering Fellow to drive human-centered design of medical devices and combination products, shaping product UI across hardware, software, packaging and labeling to ensure safe use.

The role leads AI-augmented human factors initiatives, develops user research, creates usability files, manages vendors, and partners with cross-functional teams, with up to 20% travel; advanced degrees and many years experience required.