Engineer - Human Factors

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Do you strive to make a difference in patients' lives by conducting exploratory user research, generating product ideas, providing Human Factors Engineering guidance, evaluating concepts and designs for potential use errors, defining use-specifications, and performing formative usability assessments?

If these things make you raise your hand, keep reading!

We are seeking an experienced Senior / Principal Human Factors Engineer with an advanced understanding of perceptual, cognitive, and ergonomic theories and principles, and the ability to apply this knowledge to the conceptualization, design, and evaluation of medical devices and digital health systems.

The role requires effective collaboration with multidisciplinary team leadership; to work with colleagues from design, engineering, medical, marketing, quality, manufacturing and regulatory to apply human-centered design methods through implementation of usability processes, determination of desired user profiles and environments, development of user documentation, and creation of usability files.

A successful team member will have excellent organizational, technical problem solving, and communication skills (written and verbal). They should have the ability to influence multi-functional partners, to adapt to a rapidly changing environment, and to effectively lead external consultants.

Key Responsibilities include

• Provide expert Human Factors Engineering guidance based on usability activity results and Human Factors Engineering principles
• Provide use-related input into the creation of product and system requirements based on user needs and Human Factors Engineering expertise
• Partner with design, engineering, medical, regulatory, and others to plan and conduct Human Factors Engineering activities, including but not limited to:
  • Conceptualizing, organizing, and leading the conduct of user research studies (e.g., contextual inquires, diary studies, observational studies)
  • Leading the development of protocols, study designs, and execution of formative and summative (HF Validation) usability studies
  • Conducting heuristic evaluations and expert reviews
  • Conducting use-related risk analysis
  • Leading the reporting and disposition of Human Factors Engineering evaluation findings
  • Drafting technical documents (e.g., use specifications) for usability files within the DHF and as guidance for late-stage development
  • Author Human Factors Engineering / Usability Engineering reports for regulatory submission
• Serve as an opinion leader, internally and externally, including seeking opportunities to publish and speak publicly about Human Factors Engineering
• Conduct Human Factors Engineering educational workshops and seminars to multi-functional audiences within Lilly
• Assist in internal Human Factors Engineering staff training and process improvement activities
• Assist in maintaining procedures and tools on best practices related to Human Factors Engineering

It is also important that individuals in this role ensure the following

• User capabilities and limitations and associated use-related risks are appropriately addressed in planning, requirements development, and design & engineering
• User performance characteristics and their associated benefits and risks assist in deciding among design alternatives
• Compliance to relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and FDA guidance is adequately addressed in Human Factors Engineering processes and deliverables

Basic Qualifications

• Bachelor's Degree in Human Factors / Usability Engineering or a related field (e.g., Cognitive Psychology, HCI, Biomedical Engineering, Industrial Engineering, Mechanical Engineering, etc.) with 3+ years' experience in Human Factors or MS with 1+ years of experience in Human Factors

Additional Preferences

• Experience working in a regulated environment (e.g., Medical, DOD, DOT, etc.)
• Excellent organizational, technical problem solving, and communication skills (written and verbal)
• Strong interpersonal skills and team mind-set
• Extensive experience (4+ years) applying Human Factors Engineering to the development of medical devices or combination products
• In-depth technical knowledge of Human Factors Engineering methods and deliverables throughout the entire product development lifecycle that ensures compliance to relevant standards and FDA guidance
• Demonstrated capability in the design of usability study protocols and reports including usability root cause analysis and risk benefit analysis
• Familiarity with managing consulting relationships to execute usability activities
• Experience with software and/or electromechanical systems

Additional Information

• Estimated travel (domestic and international) is approximately 20-30% per year
• This position has the option of being based either in Indianapolis, IN, Cambridge, MA or fully remote

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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