Principal Human Factors Engineer

Principal Human Factors Engineer – Medical Devices

Location: Lexington, Massachusetts, United States

Employment type: Full-time, permanent

Salary: $154,400–$242,550 per year

Travel: Up to 20%, including domestic and international travel

About the Role

An opportunity for a highly experienced Human Factors Engineering professional to lead human-centred design and usability engineering for medical devices and combination products.

The role focuses on ensuring products can be used safely and effectively by patients, healthcare professionals and other intended users. It also involves advancing AI-enabled research, risk management and digital transformation initiatives across medical device development.

Key Responsibilities

• Lead Human Factors Engineering strategy for medical devices and combination products in line with applicable regulatory requirements.
• Develop and oversee user research strategies, including AI-assisted research, digital ethnography and remote usability studies.
• Translate user needs into product, system and user interface requirements.
• Design and conduct human factors studies to evaluate device hardware, software, packaging, labelling and instructional materials.
• Lead use-safety engineering and data-driven product risk management, including predictive modelling and AI-assisted risk detection.
• Develop and manage human factors validation protocols, reports and usability engineering documentation.
• Establish regulatory strategies and ensure compliance with relevant IEC and ISO standards.
• Develop Human Factors Engineering procedures, standards and templates.
• Manage external research, design and human factors vendors.
• Support internal and external quality audits.
• Collaborate with engineering, software, clinical, regulatory, commercial, data science and quality teams.
• Mentor Human Factors Engineering Leads and provide technical guidance across projects.

Requirements

Education and experience – one of the following:

• Doctorate in Human Factors Engineering, Biomedical Engineering, Industrial Engineering or a relevant discipline, with at least 7 years of relevant experience.
• Master's degree in a relevant discipline, with at least 13 years of experience.
• Bachelor's degree in a relevant discipline, with at least 15 years of experience.

Technical expertise:

• Extensive experience in Human Factors Engineering and human-centred design for medical devices or combination products.
• Strong knowledge of usability engineering, user research and medical device development.
• Experience developing and executing human factors validation studies.
• Understanding of applicable medical device regulations, guidance and IEC/ISO standards.
• Experience with usability engineering files, design controls and regulatory documentation.
• Knowledge of product safety, risk assessment and usability-related risk management.
• Experience managing external vendors and cross-functional technical projects.
• Strong communication, stakeholder management and mentoring capabilities.

Additional focus: AI-enabled research, synthetic user simulations, predictive risk modelling and digital transformation of Human Factors Engineering processes.

Additional Information

• Full-time employee position.
• Up to 20% domestic and international travel.
• Comprehensive employee benefits available.