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 needs, usability requirements, and use errors are identified and addressed in the design process.
• Serve as a technical Design + Human Factors Lead on innovation & commercial projects. Contribute to and lead design, usability, and user research studies.
• Provide Design + Human Factors input to delivery system development and engineering groups to ensure safety, usability, ergonomics, physical user experience, and digital user experience are all considered during device development.
• Oversee and contribute to analytic human factors activities for the purposes of device design input, risk assessment and mitigation.
• Oversee and contribute to the development and execution of user evaluations at various stages of product development, including new product development and through formal FDA-mandated validation.
• Engage with Quality and Regulatory Affairs to drive the development of processes and documentation to meet quality and regulatory requirements.
• Coordinate Human Factors Engineering activities with Business Units and other internal partner organizations.
• Collaborate with external Design + Human Factors Engineering consultancies, internal stakeholders, and external partner organizations.
• Serve as an opinion leader, internally and externally, including seeking opportunities to publish and speak publicly about Design + Human Factors.
• Assist in internal Design + Human Factors Engineering staff training and process improvement activities.
• Assist in maintaining procedures and tools on best practices related to Design + Human Factors Engineering.

Basic Qualifications

• PhD in Human Factors / Usability Engineering, Industrial Design or a related field with 2+ years of experience or M.S. and 5+ years of experience

  OR

• Bachelor's Degree with 10+ years of experience.
• Experience working in a regulated environment, strong preference for medical.

Additional Skills and Preferences

• In-depth technical knowledge of Design + Human Factors methods and deliverables throughout the entire product development lifecycle that ensures compliance to relevant standards and FDA and OUS regulatory and human factors guidance.
• Experience with direct reports or in mentoring junior team members.
• Excellent organizational, technical problem-solving, and communication skills (written and verbal).
• Strong interpersonal skills and team mindset.
• Extensive experience in the development and user testing of novel medical devices or combination products.
• 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.
• Experience with combination products.
• Experience with human performance assessment tools such as eye tracking and other specialized technology to assess user-device interactions.

Additional Information

• Estimated travel (domestic and international) is approximately 10-15% per year.
• This position has the option of being based either in Indianapolis, IN, or Cambridge, MA. A remote option can be discussed with the expectation that a remote role will have an additional travel requirement, of up to 25-30%, and expectation to align work hours primarily with Eastern Standard Time.

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.

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