Overview

The R&D Engineer, Usability and Human Factors role primarily focuses on facilitating the design and development of products that reduce the risk of use related errors. This is done by collaborating with design teams, coordinating testing and composing usability related tools and regulatory documentation.

Responsibilities

Function as a technical subject matter expert on Human Factors/ Usability in medical devices including IEC Usability standards, AAMI Human Factors standards and FDA Human Factors Guidance
Author design control documentation like Usability Engineering File (UEF), Use Specifications, Task Analysis, uFMEA, etc...
Lead the development and execution of product usability testing.
Provide guidance, coaching and training to other employees on establishment of usability design control elements.
Influence the global organization on usability related policies, procedures and practices
Work with relevant R&D engineers to conduct field case research and case study observation with the ability to apply findings into human interface requirements for the purpose of concept selection/refinement, use-related risk identification and formal usability validation with intended users.
Ability to progress work independently with minimal supervision and as part of a cross-functional development team.
Must work and interact effectively and professionally with and for others throughout various levels of the global organization
Must strictly adhere to safety requirements
Maintain regular and punctual attendance
Must maintain company quality and quantity standards
Must have effective oral and written communication skills

Qualifications

Qualification/ Educational Requirements

BS in Engineering or related (Preferred degree in Human Factors, Mechanical, Biomedical, Design or similar discipline);
5 years Experience in Usability/Human Factors in medical device development
Knowledge and experience with user / use environment research, scenario development and documentation
Skilled in conducting usability evaluations, including leading, facilitation and observation & supports risk management.
Experience using analytic skills and problem solving
Current knowledge and application FDA 21CFR820, ISO 13485, IEC 62366-1, FDA Human Factors Guidance, ISO 14971

Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Physical Requirements

Works under general office environmental conditions.
Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position.

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Human Factors Usability Engineer