Lilly Senior Human Factors Engineer in Indianapolis, United States
Type of Employment:
Full-Time Employment - FTE
Do you strive to make a difference in patient lives by conducting exploratory user research, providing Human Factors guidance, evaluating concepts and designs for potential use errors, defining use-specifications, and performing formative usability assessments? If these things make you raise your hand, keep reading! We have the opportunity to match your needs.
We are seeking an experienced Senior Human Factors Engineer with an advanced understanding of perceptual, cognitive, and ergonomic theories and principles, and the ability 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 medical, marketing, engineering, quality, manufacturing and regulatory to apply human-centered design methods through implementation of usability process, 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). You should have the ability to influence multi-functional partners, to adapt to a rapidly changing environment, and to effectively lead external consultants.
Additional responsibilities include:
Provide expert Human Factors guidance to engineering and design groups based on usability activity results and design principles.
Partner with marketing, medical, engineering and others to identify unmet user needs by conceptualizing, organizing and leading the conduct of user research studies (e.g., contextual inquires, dairy studies, observational studies).
Provide use-related input into the creation of product and system requirements.
Provide direction for the development of protocols, study designs, plans and oversees study execution and vendor management, if applicable, for human factors activities throughout the early-stage product development including heuristic evaluations and formative studies.
Conduct preliminary use-related risk analysis.
Drafts technical documents (e.g., use-specification) for usability files within the DHF and as guidance for late-stage development.
Serve as an opinion leader, internally and externally, on human factors, including seeking opportunities to speak publicly about human factors.
Conducts human factors educational workshops and seminars to multi-functional audiences within Lilly.
It is also important that individuals in this role ensure the following:
User capabilities and limitations and associated use-related risks are appropriately addressed in planning, requirements development, and design & engineering.
User performance characteristics and their associated benefits and risks assist in deciding among design alternatives.
Compliance to relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and FDA guidance is adequately addressed in Human Factors processes and deliverables.
Bachelor's Degree in Human Factors / Usability Engineering or related field with 8+ years’ experience; or
Master's Degree in Human Factors / Usability Engineering or related field with 3+ years of experience or
PhD in Human Factors / Usability Engineering or related field
Experience working in a regulated environment (e.g. Medical, DOD, DOT, etc.)
Extensive experience (4+ years) in development of medical devices or combination products and their regulatory requirements.
In-depth technical knowledge of HF methods and deliverables throughout the entire product development lifecycle that ensures compliance to relevant standards and FDA guidance.
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.
Estimated travel (domestic and international) is approximately 25% per year
This position has the option of being based either at Indianapolis, IN or Cambridge, MA.
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.
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 39,000 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. #WeAreLilly
Region: North America
State: Indiana, Massachusetts
Req Id: 55151BR