US-MA, Lead, Human Factors Engineering SR0030490-MZ
To Be Completed by Hiring Manager Primary Duties Provide a brief summary describing the major role, responsibility and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable. The Lead, Human Factors Engineering will lead human factors work to support the development of devices and combination products for delivery of Takeda 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. Responsibilities Describe the essential daily job functions and include % of time spent on each. % of Time Job Function and Description 25% 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 25% With little direction, responsible for leading all activities needed to support human factors deliverables for a device or combination product development project 15% Build an internal understanding of Takeda 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 15% 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 10% Create and communicate project plans, tasks and deliverables. This includes reporting information at key milestones through clear written and verbal communications 10% 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 12 years of human factors engineering experience OR M.S. in Human Factors Engineering, or equivalent. A minimum of 8 years of human factors engineering experience OR Ph. D. in Human Factors Engineering, or equivalent. A minimum of 4 years of human factors engineering experience 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. Demonstrated ability to provide technical leadership for human factors engineering aspects of device and combination product development Understanding of user-centered design, heuristic evaluations, design of experiments, usability testing and statistical analysis 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 Understanding of Quality System Regulations Experience with operating in a regulated environment (e.g., FDA) with an understanding of associated implications for design of medical devices and combination products a plus Experience interacting with regulatory agencies via written responses and/or live meetings a plus 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 provide examples. 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%
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