Title:Senior Human Factors Engineer
Location:Ballybrit, Galway
Benefits:Top salary, bonus, pension, healthcare and excellent career opportunities

My Client:

My client is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Their 114,000 colleagues serve people in more than 160 countries.

Purpose of the role:

The Senior Human Factors Engineer plays a critical role in the design and development of rapid diagnostic products for global markets. This role applies advanced human factors engineering (HFE), usability science, and cognitive psychology to ensure safe, intuitive, and effective user interactions throughout the entire product lifecycle. The position partners closely with R&D, Clinical, Regulatory, Quality, Marketing, and Design teams to generate high‑quality usability evidence and documentation supporting regulatory submissions and product commercialisation.

Main responsibilities:

• Lead the planning, execution, and reporting of formative and summative (validation) usability studies across diverse global user groups and environments.
• Identify user needs, map workflows, define critical tasks, and guide design teams to create intuitive user interfaces and mitigate use‑related risks.
• Develop and maintain core human factors deliverables, including user profiles, task analyses, uFMEAs, and use‑related risk analyses (URRA).
• Apply advanced knowledge of human factors engineering, cognitive psychology, human‐system interaction, and user‑centered design methodologies.

• Prepare human factors documentation for FDA submissions (e.g., HFER, critical task justification, URRA) and support generation of IVDR usability evidence, including GSPR usability justifications.
• Contribute usability evidence to WHO Prequalification (PQDx) filings, including studies conducted in low‑resource or variable‑infrastructure settings.
• Ensure all human factors activities adhere to applicable standards and guidance, including IEC 62366‑1, ISO 14971, and FDA’s Human Factors Guidance, within a robust design control and quality system environment.

• Collaborate with R&D, Industrial Design, Packaging Engineering, Regulatory Affairs, Clinical Affairs, Quality Assurance, and Marketing to integrate usability insights early and continuously into product requirements and design decisions.
• Drive iterative improvements to components, packaging, labeling, instructions for use (IFUs), quick‑start guides, and user workflows based on study results and evidence‑based design principles.
• Investigate emerging technologies, methods, and trends in usability and diagnostics to strengthen the organization’s human factors capabilities.
• Communicate findings, rationale, and design recommendations to stakeholders at multiple levels, translating insights into actionable decisions supported by quantitative and qualitative evidence.

• Contribute to project planning, timeline development, and resource scoping for usability activities.
• Manage multiple priorities effectively in a fast‑paced, highly matrixed global environment.
• Demonstrate exceptional verbal and written communication skills with an ability to influence across teams.
• Provide mentorship to junior team members and contribute to the evolution of internal HFE best practices.
• Travel up to approximately 25%, including internationally.

• 6+ years planning, moderating, and analysing formative and summative usability studies for medical devices or in vitro diagnostics.
• Demonstrated experience preparing Human Factors Engineering Reports (HFER) and usability documentation supporting FDA submissions.
• Experience generating usability evidence for IVDR Technical Documentation, including GSPR usability justification.
• Experience contributing to WHO PQDx submissions, including studies performed in low‑resource settings.
• Strong working knowledge of IEC 62366‑1, ISO 14971, and FDA’s 2016 Human Factors Guidance.
• Hands‑on experience with lateral flow or point‑of‑care diagnostic devices, common user errors, and design/IFU mitigation strategies.
• Demonstrated success developing and testing IFUs, packaging, quick guides, and labelling through iterative, evidence‑based design.
• Experience running unbiased usability sessions using standardized task scripts and moderator‑bias mitigation techniques suitable for regulatory‑grade data.