Scientist (Human Factors Engineering for Drug Delivery)

Drive Innovation in Human Factors Engineering

Join a leading client to support drug delivery device projects and ensure cutting-edge pharma solutions never miss a beat. In this role, you will specialize in Human Factors Engineering (HFE), focusing on the development of secondary packaging, instructions for use, and ensuring compliance with applicable regulations and standards. You will play a key role in advancing combination product design and usability while collaborating with cross-functional teams.

Key Responsibilities

• Plan and execute Human Factors Engineering activities for drug delivery device projects.
• Develop HFE documentation for Design History Files (DHF) and regulatory submissions, including Use Risk Assessments.
• Apply best practices in Human Factors Engineering.
• Collaborate with HFE leads and team members to plan and execute projects effectively.
• Collect and analyze data on user capabilities and known use challenges with combination products.
• Participate in the planning and execution of formative and summative studies.
• Ensure compliance with relevant regulations, standards, and guidance.
• Address individual project challenges autonomously.
• Deliver activities within agreed timelines and quality standards.
• Maintain knowledge of legislation, regulations, guidance, and industry trends related to combination products.

Essential Skills and Requirements

• Expertise in IEC 62366 standards and related regulatory guidance.
• Proficiency in Use Risk Assessments and developing instructions for use.
• Academic qualifications in Ergonomics, Psychology, or a relevant Science/Engineering field.
• Familiarity with nebulizer technology (strongly preferred).
• Experience with injection devices (preferred).
• Strong scientific background in combination products and drug delivery systems.
• Ability to work collaboratively across all levels and independently with strong organizational and communication skills.
• Knowledge of regulatory and quality standards, including documentation for regulatory submissions.

To be considered for this role, you must have the right to work in this location or hold an EU passport.