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Job Description
Lead Senior Human Factors Engineers for R&D operations, leading human factors and usability validation for medical device products, collaborating with cross-functional teams to meet user needs and regulatory requirements throughout the product lifecycle.
Key responsibilities:
- Lead and participate in human factors studies, including formative and summative evaluations.
- Gather insights into user groups, environments, and needs to inform product design.
- Plan and execute usability validation studies, defining risk-based acceptance criteria and managing sample size justifications.
- Ensure compliance with US/EU regulations and medical industry standards for human factors.
- Collaborate with internal stakeholders and manage external vendors for validation services.
- Document and communicate usability findings, ensuring alignment with product development.
Requirements:
- MS/Ph.D. in Biomedical Engineering or related field, with 5+ years in medical device human factors validation.
- Experience working with end users, preferably in a hospital or clinical setting.
- Strong knowledge of ISO standards and FDA guidance on usability.
- Excellent communication skills and attention to detail.
- Hands-on experience in usability testing and risk management.
Hourly rate: €70-90/hour DOE.