Location: Dublin
Job Purpose
The Senior Human Factors Engineer is responsible for ensuring that FIRE1 product and systems are safe, effective, and user-friendly.
Responsibilities
- Developing Human Factors Engineering (HFE) Strategies: Lead and support HFE activities throughout the product development lifecycle, from early-stage development to post-market support.
- Conducting User Research: Perform ethnographic studies, use-related risk analysis, and usability testing (formative and summative) to gather user insights.
- Design and Usability Testing: Design and execute user studies to inform the design process and ensure the device meets user needs and regulatory requirements.
- Collaboration: Work closely with cross-functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing.
- Documentation: Author HF deliverables for device design history files and write HF sections for health authority submissions.
- Process Improvement: Enhance internal HFE processes to ensure consistency, compliance, and efficiency.
Experience & Education
Essential: Bachelor’s or Master’s degree in Engineering/Medical Device Design preferably a degree which focuses on human factors design.
Desirable: 6 + years experience in medical Device environment with knowledge of medical device products and associated regulatory requirements
Skills
- Proficiency in human factors engineering principles and methodologies.
- Experience with relevant standards and regulations (e.g., IEC 62366, FDA guidance, ISO 14971).
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
- This role is essential for developing medical devices that are not only innovative but also intuitive and safe for users
Reporting
Reports to R&D Manager
