Careers that Change Lives
Position Description:
In this position, the Human Factors Engineer will conduct Human Factors engineering of cardiac surgery medical devices and systems in accordance with Medtronic Cardiac Surgery standard operating procedures, IEC/ANSI/AAMI 62366, and other applicable regulatory standards. S/he will apply knowledge of human performance (perceptual, cognitive, and motor skills) and Human Factors Engineering techniques throughout all phases of product development, as well as pre-design control and post-product launch.

Position Responsibilities:

• Conduct the following Human Factors Engineering activities with limited guidance of from senior Human Factors Engineering staff:
• work with Marketing to assess and identify product development opportunities.
• conduct exploratory workflow analysis and field research.
• Must be able to author task analyses
• collaborate with systems engineering to establish traceable system requirements.
• collaborate with design assurance or quality assurance to conduct UFMEAs and contribute to DFMEAs.
• partner with mechanical, electrical, software, packaging, and reliability engineers to create hardware and software user interface design concepts and prototypes
• conduct formative usability testing
• analyze usability study data and create appropriate documentation of your findings
• communicate usability test findings to project teams
• collaborate with technical communications team members to support creation of information for safety
• work with post-market quality assurance to cull use-related field complaint information

A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Applies human centered principles, methodologies, and technologies to the design of human-machine systems and products.
• Develops and implements research methodologies and both qualitative and quantitative analysis plans to test and evaluate new concepts and developmental prototypes used in all phases of products development and processes.
• Designs and executes tests to simulate product use for the purposes of user need investigation, concept exploration/selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces and overall user experience.
• Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans to inform the design direction of new product development.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have
Experience:

• independently assess and scope Human Factors Engineer engineering needs for a project.
• independently audit the design history files of a released product and determine what Human Factors Engineer engineering gaps are present, and independently scope the required Human Factors Engineer remediation work. Must be able to independently perform the work and/or direct and oversee internal and/or external parties who conduct the work.
• experience working on CAPA projects as a Human Factors Engineer
• experience collaborating as a Human Factors Engineer with other non-engineering design disciplines such as product designers, industrial designers, and graphic designers.
• Must know the difference between UX and Human Factors Engineering. Must know how to collaborate with UX designers.
• Must be able to clearly explain to project teammates and upper level management what the difference is between Human Factors Engineering and the other design disciplines.
• Must have experience working with System Engineers
• Distinguish between customer needs, user needs, and technical needs. Must have experience working early with Marketing on new product development projects.
• experience interviewing users and customers.
• experience leading use error analysis efforts and/or co-leading UFMEAs.
• experience writing usability test validation protocols that explicitly lay out traceability of design controls to DFMEAs and UFMEAs to task analyses and user needs and system requirements.
• experience as the principal investigator and lead moderator of usability design validation tests.
• Prepare design illustrations for presentation of design concepts. Contribute to the development of physical mock-ups and interactive prototypes of design concepts.
• Plan and conduct end-user evaluations of product concepts, analyze data, document evaluation methods and results, and present design recommendations to the product team.
• Familiar with regulatory and industry requirements for Human Factors Engineer in medical device development.
• Represent the Human Factors Engineer discipline throughout the organization through expert guidance and education.
• Able to travel globally to support project needs as required.

Education:

• Bachelor's Degree in Human Factors Engineer-related discipline
• Graduate degree in Human Factors Engineer, Kinesiology, Psychology, Industrial Design, or a related field.

Specialized Knowledge or Skills:

• Advanced knowledge in human physical and psychological capabilities and limitations, and methods used to study them.
• Experience planning and conducting human subjects research studies, analyzing data, and reporting results verbally and in writing

Desired/Preferred Qualifications:

• Experience designing in a regulated technical (preferably medical device) environment.
• Expert with Microsoft Office Suite
• Experience designing with Adobe Design Suite

Intriguing Specialties:

• 3D CAD concepting and printing
• Data visualization
• Video production
• Systems Engineering

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)