Intellectt INC
Location
Burlington, MA | United States
Job description
Senior Human Factors Engineer, R&D
Burlington, MA
Description
We are seeking an experienced, high caliber Senior Human Factors Engineer to support product
development efforts by performing clinical engineering tasks such as investigating, defining, analyzing,
documenting, and testing activities associated with the development of heart failure devices. Human
Factors Engineering performs additional analyses and/or interviews to determine the requirements and
constraints on the system and is accountable for resolving cross-functional issues. Work requires the
application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques.
The Senior Human Factors Engineer will:
Perform all activities necessary to complete human factors engineering projects with minimal
oversight. Activities include, but are not limited to:
Conducting ethnographic user research to identify user needs
Translating user needs to requirements and product design concepts
Developing prototypes to explore and validate product design concepts
Performing workflow, task and use error analyses and/or UFMEAs
Developing user-facing instructions
Conducting formative usability testing
Conducting summative usability validation testing
Participate on development program teams to ensure sound human factors principles are
considered and implemented.
Participate in teams to design solutions to usability issues
Provide input to the risk management process, including risk brainstorming, and identification of
patient harms and associated severity/probability.
Foster collaboration with cross-functional teams and leaders to drive work to completion and
resolve issues.
Support all company initiatives as identified by management and in support of Quality
Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory
requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory
requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of
employees, customers, contractors, and vendors
Perform other related duties and responsibilities, on occasion, as assigned
Required
Bachelor's Degree in human factors engineering, human computer interaction, human factors
psychology, or a related Engineering degree with Human Factors experience.
5+ years of R&D experience in medical device development and/or other highly regulated
industry. (Advanced degree may substitute for some experience.)
General knowledge of user interface design, human perception, cognition, anthropometry,
biomechanics, human behavior, and physiology.
Demonstrated ability to effectively integrate information from to varied disciplines including
Engineering, Marketing, Clinical Affairs, and Regulatory Affairs.
Demonstrated leadership in team settings, including the ability to set goals and provide positive
and constructive feedback respectfully to build positive relationships and improve business
results
Meets deadlines in a timely manner
Ability to leverage and/or engage others to accomplish projects
Ability to travel, including internationally
Preferred
Master's Degree in human factors engineering, human computer interaction, human factors
psychology, or a related Engineering degree with Human Factors experience
Class III implantable medical device experience
Excellent interpersonal and communication skills (verbal, written, presentation), with ability to
clearly communicate complex information across all levels of the organization Strong analytical,
problem-solving skills
Ability to work in a highly matrixed, geographically diverse, fast-paced business environment
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