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 concept
Performing workflow, task and use error analyses and/or UFMEAs
Developing user-facing instructions
Conducting formative usability testin
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 issue
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 regulatoryRequirements
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 includingEngineering, 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 factorspsychology, 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 t
clearly communicate complex information across all levels of the organization Strong analytical, problem-solving skill
Ability to work in a highly matrixed, geographically diverse, fast-paced business environment
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Staffing and Recruiting
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