Job Description
Senior Human Factors Engineers sought for R&D operations in Dublin, leading human factors and usability validation for medical device products.
STEM Recruitment Partners are working with a medical device company based in Dublin that is seeking 2 x Senior Human Factors Engineers for their R&D operations.
The role involves collaborating with cross-functional teams to ensure products meet user needs and regulatory requirements throughout the product lifecycle, in compliance with ISO standards and FDA guidance on human factors.
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.
Qualifications:
- 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.
Skills: Human Factors, Usability, Medical Devices, Seniority level Mid-Senior level, Employment type Full-time, Job function Information Technology, Industries Civil Engineering