Job Description

This is an onsite position. Local candidates only



Senior Human Factors Engineer, R&D
Leading an active lifestyle is important to the many people we serve. In Client's Heart Failure division, we're advancing the treatment of heart disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives.



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.
Each employee can make a difference at the client and has the power, either individually or as a team, to influence the success of the company. We value people with great ideas who partner with others internally and externally to take action and accomplish goals.



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

• 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
• bility to leverage and/or engage others to accomplish projects • Ability to travel, including internationally
• MS Office Suite
• Meets deadlines in a timely manner
• bility to leverage and/or engage others to accomplish projects
• bility to travel, including internationally

• 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
• bility to work in a highly matrixed, geographically diverse, fast-paced business environment
• If someone has working knowledge of Regulation 623.66 and FDA this is a nice to have.

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