Position Overview: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 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, adapt to a rapidly changing environment, and to effectively lead external consultants.
Key Responsibilities- 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
- 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
- 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
Basic Qualifications:- Bachelor's degree in Human Factors / Usability Engineering or a related field (e.g., Cognitive Psychology, HCI, Biomedical Engineering, Mechanical Engineering, etc.) with 1+ years' experience in Human Factors.
- 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
Additional Preferences:- Master's degree in a Human Factors/Usability or related field.
- Extensive experience (3+ 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
- Experience in the design of usability study protocols and reports including usability root cause analysis and risk benefit analysis
- Familiarity with managing or participating in external consulting relationships to execute usability activities
- Experience with software and/or electromechanical systems
- Experience in risk management
- Experience using AI tools in technical or research work, with the judgment to know where they are reliable and where human expertise is still required.
Other Information:- The location for this position is Indianapolis, IN.
- Domestic/international travel ~ 20-30%.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$67,500 - $151,800
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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