Engineer III, Human Factors Engineering

3316 Takeda Development Center Americas•Lexington, MA

4d•Onsite

About The Position

The Engineer III, Human Factors Engineering (HFE) is responsible for supporting the Human-Centered research, design, and development of Medical Devices and Combination Products. This role contributes to the design and evaluation of product user interface, including hardware, software, packaging, labeling, and instructional materials, to help ensure safe and effective use of the product by the intended users in the anticipated use environment. The Engineer III, HFE also contributes to the adoption of digital and AI-enabled Human Factors Engineering tools and methodologies.

Requirements

Master's degree of Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry.
OR, Bachelor's degree and 2+ years of relevant industry experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry
OR, Associate’s degree and 4+ years of relevant industry experience in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry

Responsibilities

Supporting the development and execution of Human Factors Engineering activities in compliance with regional regulatory guidance.
Contributing to User Research planning and execution in accordance with Quality Management System requirements.
Supporting Human Factors product and system level requirements aligned with Target Product Profile.
Conducting exploratory research and AI-augmented research to generate high-quality user data, including digital ethnography, remote usability platforms, and synthetic user simulations.
Executing Human Factors studies to iteratively evaluating product user interface – including hardware, software, packaging, instructional material, and training.
Supporting data driven risk management approaches, including predictive modeling.
Contributing to Human Factors Validation Protocols and Reports.
Supporting the selection, coordination, and management of Human Factors and User Research vendors.
Developing Usability Engineering Files in compliance with IEC and ISO standards.
Contributing 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.
Partnering with cross-functional colleagues across mechanical engineering, software, clinical, regulatory, commercial, data science, digital, and quality disciplines.
Supporting internal and external quality audits.
Communicating with internal and external key stakeholders.