The Lead, Human Factors Engineering will lead human factors work to support the development of devices and combination products for delivery of Shire’s wide portfolio of drugs and biologics. As part of human factors work, the Lead will also be responsible for planning and executing early stage user research, focusing on unmet user needs, to inform development.
Describe the essential daily job functions and include % of time spent on each.
% of Time
Job Function and Description
Work with external human factors consultants to plan, conduct and report out early stage user research, including developing proposals for user research for different products
With direction, responsible for leading all activities needed to support human factors deliverables for a device or combination product development project
Build an internal understanding of Shire product users through synthesis of user research outputs. This includes creating tools to organize and reference user research outputs for device and combination product development
Actively participate on device and combination product development teams to ensure human factors engineering and user research inputs are considered and implemented at appropriate points in the development process
Create and communicate project plans, tasks and deliverables. This includes reporting information at key milestones through clear written and verbal communications
Lead efforts to develop processes and procedures that align to company initiatives and relevant human factors engineering standards
Education and Experience Requirements
B.S. in Human Factors Engineering, or equivalent. A minimum or 10 years of human factors engineering experience – OR –
M.S. in Human Factors Engineering, or equivalent. A minimum of 5 years of human factors engineering experience – OR –
Ph. D. in Human Factors Engineering, or equivalent.
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be
representative of the knowledge, skills, and abilities required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
Ability to provide technical leadership for human factors engineering aspects of device and combination product development
Experience in the design and conduct of user research (e.g., discussion guide development, session moderation)
Experience implementing HFE standards and guidances
Ability to draw conclusions and make recommendation based on technical inputs from multiple sources
Ability to be collaborative and flexible in approach to solving human factors challenges
Strong communication skills and ability to perform within a cross-functional team environment
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the
Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
Responsible for determining approach for human factors work, including tailoring HF deliverables based on risk associated with the product (i.e., use-related risk, regulatory risk, business risk, etc.). This includes determining the scale and timing of required user research, formative and summative human factors evaluations.
Internal and External Contacts
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the
job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and
This role interacts extensively with a wide variety of internal contacts, most notably individuals in engineering, quality, clinical & medical affairs, regulatory affairs, commercial, legal and purchasing.
This role interacts extensively with external HF consultants. The Lead will be responsible for selecting consultants to perform HF research and studies, and managing the work of consultants throughout the engagements.
Other Job Requirements
List any other job requirements, including travel, physical abilities required, etc.
Some travel, up to 25%