DBSI Services · 4 months ago
Principal Human Factors Engineer specialized in Lifesciences (Medical
Fort Worth, Texas, TX 76006
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $110K/yr
4+ years expDBSI Services is a rapidly growing staffing agency specializing in various industries, including medical devices. They are seeking a Principal Human Factors Engineer specialized in Lifesciences to apply user-centered design principles and Human Factors Engineering methods in the development of Alcon’s Digital Health Suite and Surgical Instrumentation projects.
ConsultingRecruitingStaffing Agency
Responsibilities
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
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
Qualification
Required
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)
Benefits
401(k)
401(k) matching
Relocation bonus
Company
DBSI Services
DBSI Services is an engineering and technical staffing company with 25 years of expertise in recruiting the best talent.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase