Shire Lead, Human Factors Engineering in Lexington, Massachusetts

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

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%

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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, gender identity, 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.