What are the responsibilities and job description for the Human Factors Engineer position at Zenotis Group?
PFB is the JD for the role of Principal Human Factors Engineer in Lake Forest, CA/ Fort Worth, TX. (must be able to travel between sites to support projects).
Job Description: Contract Principal Human Factors Engineer specialized in Lifesciences (Medical Devices)
As a Principal Human Factors, this role will support the Surgical Instrumentation and Digital Health Suite products for the customer in Lake Forest, California, USA.
Job duties and responsibilities will include:
· Apply user-centered design principles to the research, design, and development of Customer’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 Customer’s 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 Customer’s 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 Customer’s 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)
