Human Factors Engineer

GSK • Collegeville, PA

19h • Hybrid

About The Position

As a Human Factors Engineer at GSK, you will help design safe, easy-to-use healthcare solutions by bringing user needs and insights into the design process. You will collaborate with cross-functional teams throughout medical device development, conduct user studies and risk assessments, and contribute to regulatory documentation related to human factors and usability. The role is based at GSK’s Research & Development site in Ware, Hertfordshire, United Kingdom, with a flexible hybrid working arrangement and regular on-site presence. Occasional travel may be required.

Requirements

• Degree in Mechanical Engineering, Biomedical Engineering, Human Factors, or a related field.
• Proven experience applying human factors engineering principles in medical device or combination product development.
• Understanding of human factors regulatory guidelines, including IEC 62366 and FDA usability requirements.
• Experience planning and conducting human factors studies, including usability testing and risk assessments.
• Knowledge of integrating user needs and risk information into design and validation activities.
• Strong communication skills for working effectively with cross-functional teams and external partners.

Nice To Haves

• Experience with global regulatory submissions and authoring sections of human factors files.
• Ability to analyse user data and translate insights into clear design improvements.
• Familiarity with design for manufacture principles.
• Strong organisational skills and ability to manage multiple projects and deadlines.
• Proactive team-player approach and ability to adapt to changing priorities.
• High attention to detail and commitment to quality.

Responsibilities

• Lead human-centred design activities throughout all stages of device development to ensure products meet user needs.
• Plan and execute user studies, including early handling tests and design validation, to gather meaningful feedback.
• Conduct user-related risk assessments and integrate findings into design decisions to improve safety and usability.
• Work with engineering, regulatory, clinical, and quality teams to address design and regulatory challenges.
• Manage relationships and communications with external vendors and internal stakeholders to support project goals.
• Prepare clear, accurate human factors and usability sections for regulatory documentation.

What This Job Offers

• Job Type: Full-time