Senior Human Factors Engineer

Responsibilities

• Lead human factors efforts for programs from concept through post market support, supporting and influencing usability activities for product lines and programs with minimal oversight
• Develop an understanding of intended use environments gained through time spent in the field, with a good understanding of intended user types formed through interactions with users
• Require work on problems of diverse scope that impact the broader program team and business, and contributes to projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations
• Network with key contacts outside own area of expertise, contributes information to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development

• University/Bachelor's Degree in Human Factors Engineering (HFE), or Usability Engineering
• 4 to 6 years work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required.
• Demonstrated ability with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions
• Medical Device product development or experience working in a highly regulated industry is a strong plus.
• Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus
• Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation
• Ability in planning, executing, documenting, and reporting usability testing, including moderation of studies
• Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering
• Good knowledge of the ISO 14971 and IEC 62304 are a plus
• Fluent in English.
• German and French are an advantage
• Ability to travel up to 20%, domestic and international is required

Demonstrates expertise in Human Factors Engineering and Usability Engineering, with a strong focus on user interaction, usability testing, and regulatory compliance in product development. Proficient in stakeholder negotiation and cross-functional collaboration to ensure alignment with customer needs and technical applications.