Advisor / Sr. Advisor - Lead Human Factors Engineer

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.

Organization Overview:

Do you strive to make a difference in patients’ lives by conducting exploratory user research, generating product ideas, providing Design and Human Factors guidance, generating, and evaluating concepts and designs, defining use specifications, and performing usability assessments?

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

We are seeking an experienced 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 the 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, adapt to a rapidly changing environment, and effectively lead external consultants.

Key Responsibilities include:

• Act as internal HF regulatory expert in providing independent HF regulatory assessment of HF content that is ready for regulatory submission to identify potential regulatory risks and provide recommendations on navigating through least burdensome approach to maximize HF submission success.

• Act as one of the HF department representative for creating successful partnerships and achieving internal buy-in with other Lilly functional groups such as innovation (DDNPI), risk management, global labeling, device regulatory, digital health, etc. and to further organizational understanding and appreciation of the importance of applying HF early in all product development

• Support creation of department HF-related grand rounds/training topics and associated content to (a) optimize HF department’s collective understanding, knowledge, and skillsets, (b) enhance consistency within the department through sharing of lessons-learned with respect to HF approaches and HF documentations across HF projects at Lilly, and (c) to bridge understanding between medication use process and HF process to optimize product design and to minimize use errors and medication errors across different element of the product user interface including carton labels and labeling, IFU, and device design

• Harmonize current global HF regulatory expectations with existing organizational requirements, HF templates, SOPs/best practices to (a) facilitate remediation of HF documentations for legacy products, (b) leverage institutional knowledge, regulatory landscape and available data across legacy programs with platform products and (c) maximize efficiency for generating HF data and documentation for new products

• Collaborate closely with clinical team, risk management team and systems engineering team and other functions to harmonize expectations and ways of working together that satisfy Design History File/Design Control requirements and HF specific requirements such as development of user needs, hazard analysis, use-failure mode and effect analysis, design input requirements, design specifications, design outputs and verification and validation

• Collaborate with other senior HF leaders to support development of HF department annual metrics and evaluation methods to achieve efficient department operation, consistent scientific approach and transparent communications within the HF department and cross-functionally

• Drive customer and patient-focused product design innovation by employing human-centered design principles and executing human factors engineering processes in compliance with standard operating procedures.

• Lead post-approval usability assessments to leverage findings that support improvements in subsequent iterative product development.

• Work closely with a cross-functional development team throughout a product development effort to ensure that user n