Shire Lead, User Research & Human Factors Engineering in Lexington, Massachusetts

Primary Role

The Lead, User Research & 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.

Essential Functions


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 direction, responsible for leading all activities needed to support human factors deliverables for a device or combination product development project [25%]

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 [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 [15%]

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 [10%]

Education & 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 and Competencies

  • 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

Other Job Components

Complexity and Problem Solving

  • 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

  • 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 Requirements

  • Some travel, up to 25%

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.