Principal Human Factors Engineer specialized in Lifesciences (Medical Devices)

Job Title: Principal Human Factors Engineer specialized in Lifesciences (Medical Devices)

Location: Fort Worth, TX

 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)