At Beyond Conception, we recognize that successful combination products and medical devices must seamlessly integrate user needs, safety, and regulatory compliance. Our Human Factors Engineering (HFE) service is designed to support pharmaceutical and medical device companies in developing products that are intuitive, safe, and effective for end users.
As part of our development, we are seeking a new team member :
Key Responsibilities:
Project Leadership: Lead HFE projects for MDs/CPs, from preliminary user research to final HFE validation.
User Research: Conduct user research (empirically through field studies, experimental set-ups, or by means of literature reviews, analyses and anthropometric research).
User Interface Requirement and Specifications: Contribute to User Interface requirements definition and provide justifications, define tasks/steps (Task Analysis).
Risk Management: Contribute to hazard and use-related risk analysis of MDs/CPs.
Usability Testing: Write and review HFE study protocols (formative/summative), supervise study execution, analyze results, and develop actionable recommendations.
Instructional/training material: Develop and assess instructional (e.g., Instructions for Use) and training material for end-users including lay users.
Known Use Problems: Analyze post-marketing data in light of HFE requirements.
Regulatory Compliance: Ensure that HFE activities closely align with latest regulatory guidelines (e.g., FDA, ISO and contribute to successful submissions to Health Authorities.
Collaboration: Work collaboratively with cross-functional teams, including engineering, design, and quality assurance, to integrate HFE considerations throughout the product lifecycle.
Mentoring: Mentor junior consultants and team members, sharing your expertise and fostering a culture of continuous learning within the team.
Meeting Attendance: Attend project meetings and client discussions, presenting findings and recommendations related to HFE studies and user insights.
Profile:
You are a proactive and skilled HFE professional with a passion for developing safe and effective MDs/CPs. Your strong analytical skills and user-centered mindset enables you to provide insightful recommendations that enhance product usability and safety.
You possess:
8-12 years of relevant experience in HFE/usability Engineering within the Medical Device or pharmaceutical industry.
A solid understanding of HFE principles, methodologies, and tools.
Proven experience in managing HFE projects, including developing and executing usability studies and interpreting data to drive product improvements.
Knowledge of applicable regulatory requirements related to human factors and usability, including ISO 62366, ISO 14971, FDA, and EU MDR requirements.
Strong communication and interpersonal skills, with the ability to effectively engage with clients and collaborate with multidisciplinary teams.
A university degree in a relevant field, such as HFE, cognitive psychology, biomedical engineering, industrial design or a related discipline.
Fluency in English is required.
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