Job Description

Principal Human Factors Engineer specialized in Lifesciences (Medical Devices)

Specialized Skill Sets:

Apply user-centered design principles to the

Research, design, and development of Alcon’s Digital Health Suite and Surgical Instrumentation projects.

• Apply Human Factors Engineering (HFE) methods and principles to design and develop products that meet customer technical/functional specifications as well as manufacturing cost/efficiency requirements.
• Accountable to delivering on traditional HFE activities and deliverables such as HFE Plans,
• Development of Task Analysis to support Risk management activities, planning and conducting usability evaluations, cognitive walk-throughs, data analysis to identify opportunities and control risks,

effectively report on formative and summative evaluation results, and proactively present recommendations to product teams.

• Author Human Factors artifacts required for regulatory compliance,
• specifically IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices.

Supportive requirements:

• This specialized skillset works integrally with product teams to ensure optimal usability characteristics and use safety of current and future Alcon products.
• This position serves to identify, define, analyze, validate and report on Human Factors Engineering and Usability considerations to ensure they are incorporated in the design process related to Alcon products.
• The position also involves advocacy for end users through the conduct of interviews or surveys of users or customers to collect information on topics such as use-related requirements, use risks, needs, user profiles, task analysis and user interfaces.
• Additionally, the position involves needs assessment of the user-interface elements and usability characteristics of both current and future Alcon products, with special emphasis on aspects related to use safety.
• The contracted service is accountable for ensuring user needs and requirements are translated into design concepts in collaboration with the product design teams.
• Maintain awareness of the state-of-the-art methods as applied to life-sciences / medical device industry.
• The contracted service is expected to plan and own their activities including collaborating with multi-disciplinary teams, including design, engineering, marketing, quality, regulatory, and clinical areas.

 Candidate minimal requirements:

• Bachelor’s Degree or Equivalent years of directly related experience (Assoc.+11 yrs; M.S.+5 yrs; PhD+4 yrs)
• The ability to fluently read, write, understand, and communicate in English.
• At least 4 Years of Experience delivering HFE support of medical device (SiMD, SaMD, etc) development
• Must have delivered the full HFE file to support at least one successful medical device FDA approval and IEC 60601-1-6 certification (IEC 62366 TRF)