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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 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 advancing patient safety, usability, and effectiveness across medical devices and drug-led combination products? The DDCS Human Factors Team proactively identifies and mitigates use-related risks before they reach patients, ensures products are intuitive and accessible, and supports therapeutic goals through reliable, efficient, and context-aware interfaces.

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

We are seeking an experienced Senior / Principal Engineer with an advanced understanding of pharmaceutical and/or delivery device development with the learning agility and ability to apply Human Factors discipline 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 documentation.

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:

+ Act as a Human Factors Engineer within cross functional combination product development teams within DDCS.

+ Provide expert Human Factors Engineering guidance to cross functional combination product development teams based on usability activity results and Human Factors Engineering principles

+ Provide input into the creation of combination product and system requirements based on user needs and Human Factors Engineering expertise

+ Document user capabilities and limitations and associated use-related risks are appropriately addressed in planning, requirements development, and design & engineering

+ Document user performance characteristics and their associated benefits and risks assist in deciding among design alternatives

+ Maintain compliance to relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and ensure FDA guidance is adequately addressed in Human Factors Engineering processes and deliverables

+ Partner with design, engineering, medical, regulatory, and other functions 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

+ Evolve into an opinion leader, internally and externally, including seeking opportunities to publish and speak publicly about Human Factors Engineering

+ Participate in Human Factors Engineering educational workshops and seminars to multi-functional audiences within Lilly

+ Assist in internal Human Factors Engineering staff process improvement activities

+ Assist in maintaining procedures and tools on best practices related to Human Factors Engineering

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 or Master’s degree with 1+ years of experience in Human Factors or in pharmaceutical or delivery device system development.

Additional Preferences:

+ Excellent organizational, technical problem solving, and communication skills (written and verbal)

+ Strong interpersonal skills and team mind-set

+ Experience applying Human Factors Engineering to the development of medical devices or combination products

+ Technical knowledge of Human Factors Engineering methods and deliverables throughout the entire product development lifecycle that ensures compliance to relevant standards and FDA guidance

+ Experience in the design of usability study protocols and reports including usability root cause analysis and risk benefit analysis OR any other human subjects research study design.

+ Familiarity with managing or participating in external consulting relationships to execute activities

+ Experience with software and/or electromechanical systems

+ Experience in packaging systems

+ Experience in risk management

Additional Information:

+ Estimated travel (domestic and international) is approximately 20-30% per year for human factor study conduct.

This position is based in Indianapolis, IN.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$64,500 - $167,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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