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.

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:

• 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.

• 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 or a related field with 2+ years of experience or M.S. and 5+ years of experience
   OR

• Bachelor's Degree with 8+ years of experience.

• Experience working in a regulated environment, strong preference for medical.

• Must have 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 for medical devices and combination products.

Additional Skills

• Excellent organizational, technical problem-solving, and communication skills (written and verbal).

• Strong interpersonal skills and team mindset.

• Demonstrated capability in the design of usability study protocols and reports including usability root cause analysis and risk-benefit analysis.

• Extensive experience in the development and user testing of novel medical devices or combination products.

• Familiarity with managing consulting relationships to execute usability activities.

• Experience with software and/or electromechanical systems.

• Experience with combination products.

• Experience with direct reports or in mentoring junior team members.

• 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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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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