Human Factors Engineer

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

PRIMARY FUNCTION

This position in Abbott Vascular Division would be responsible for human factor support that would influence the design and evaluation of next generation and on-market product lines. Responsibilities will cover, but not limited to, designing and executing usability tests to obtain user feedback, determine usability requirements, support risk assessment activities and be responsible for deliverables according to the Abbott Vascular human factors procedure. The main objective of these activities is to produce safe, reliable, easy-to-use/intuitive, and easy-to-maintain medical products in furthering the Abbott goals of developing products that are compelling for our customers. This position will be located in our Santa Clara office.

PRIMARY RESPONSIBILITIES

·  Apply knowledge of human factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to product development
·  Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization
·  Deliverables include, but are not limited to: Human factors engineering files; Task analyses; Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs
·  Develop collaborative working relationships with other functions across the organization, including but not limited to the following: work with
·  R&D teams to design and develop user interfaces (hardware, software, labeling, instructions and training) and develop user requirements
·  Engineering Quality to ensure that the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business
·  Regulatory Affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
·  Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering
·  Organizes and manages work to deliver programs, leads in the execution of assigned work.  Prioritizes tasks by distinguishing urgent from important tasks and asses cost/benefit trade-offs.
·  Plans and executes the department strategy to deliver upon responsibilities; gathers information, frames problems, devises/executes plans, tracks progress and adjusts/measures success within scope of responsibility to improve development efforts. 

Required Experience and Qualifications

·  Bachelors in science or engineering or equivalent
·  Minimum 5 years of work experience in medical devices
·  Ability to work autonomously or in a team setting with high-level direction
·  Proven ability to work with multidisciplinary teams
·  Ability to navigate and perform in a fast paced, highly regulated environment with an understanding of design controls and quality systems
·  Excellent verbal and written communication and presentation skills
·  Organized and detail-oriented
·  Multitasks, prioritizes and meets deadlines in timely manner.

Desired Experience and Qualifications

·  Master’s degree or Ph.D. in Human Factors/Usability/Ergonomics/User Experience, Industrial Engineering, Cognitive Psychology, Computer Science or related Engineering or Science.
·  Minimum 5 years general human factors/usability engineering experience or 3 years medical human factors/usability experience
·  General knowledge of user interface design, human perception, cognition, anthropometry, biomechanics, human behavior, and physiology
·  Experience in usability and testing methodology, use scenario development, contextual inquiry, conducting usability evaluations, and questionnaire/survey development
·  Understanding of risk and use error analysis
·  Experience designing solutions to usability issues
·  Familiarization with medical product design regulations, regulatory guidance and standards
·  Project management
·  Ability to travel approximately 15%, including internationally.

     

JOB FAMILY:

Product Development

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Santa Clara : Building B - SC Floor-2

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 15 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf