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.
We are seeking a Human factors engineer to lead human factors activities for development of Lilly's drug delivery devices/systems within DDCS. In this role, you will actively contribute to the design, execution and reporting of human factors engineering methods and activities across device and packaging programs according to current regulations and appropriate guidelines within the medical device and bio-pharmaceutical industries. Effective collaboration with medical, marketing, engineering, quality, manufacturing and regulatory team members to apply human-centered design methodologies through usability process, determination of desired user profiles and environments, development of user documentation, and usability file documentation is essential in this role. You should possess excellent organizational, technical problem solving, and communication skills (written and verbal). If you are an individual with demonstrated ability to be a team player, to influence cross functional partners and to adapt to a rapidly changing environment this is the role for you. Responsibilities of this role include:
- Provides inputs to the development of protocols, study designs and plans. Oversees study execution and vendor management, if applicable, for all usability engineering / human factors activities including summative and formative human factor studies, heuristic evaluations and user research
- Drive customer and patient-focused product innovation by executing the human factors engineering processes in compliance with standard operating procedures.
- Works 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.
- Contribute to the analytic human factors activities (e.g., use FMEA, task analysis, heuristic evaluation) for the purposes of "design input," risk assessment and mitigation, and protocol development.
- Contribute to the development and execution of formative and summative evaluations at various stages of product development from early prototypes through formal FDA-mandated validation.
- Work closely with design engineers and R&D Management to ensure the HF/UE process is followed through all phases of the system lifecycle.
- Engage Quality and Regulatory to drive development of processes documentation to meet regulatory requirements.
- Collaborate with external Human Factor Engineering consultancies, internal stakeholders and partner organizations.
- Serve as an individual technical contributor for the Human Factors engineering team.
- Contribute to and potentially lead usability and user research studies from early to late stage of device development providing input to device and packaging design and development.
- Provides Human Factors input to delivery system development and engineering groups based on usability activity results.
- Prepares technical documents for usability files within the DHF and as input to regulatory submission.
Additionally, you should ensure user capabilities and limitations and their associated use-related risks are appropriately addressed in planning, requirements development and risk management. You should evaluate user performance characteristics and their associated benefits and risks assist in deciding among alternatives. You should have a strong knowledge in compliance to relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance is adequately addressed in Human Factors processes and deliverables.
- Bachelor of Art's or Bachelor of Science degree in Engineering or related Sciences with specialization in Human Factors / Usability Engineering.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
- Experience (1+ years) in the execution of HF methods and creation of HF deliverables
- Demonstrated ability to collaborate effectively with cross-functional team leadership 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
- Demonstrated ability to collaborate on teams, to influence cross functional partners, and to adapt to a rapidly changing environment
- Excellent organizational, technical problem solving, and communication skills (written and verbal)
- MS/ PhD in Engineering or related Sciences with specialization in Human Factors / Usability Engineering in the Medical or Pharmaceutical industry
- In-depth technical knowledge of HF methods and deliverables throughout the entire product development lifecycle that ensures compliance to relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance
- Experience with Task Analysis, usability testing, analytic assessments and empirical methodologies.
- Demonstrated capability in the execution of usability study protocols.
- Demonstrated capability in creating usability study reports including usability root cause analysis and risk benefit analysis.
- Estimated travel (domestic and international) is approximately 25% per year
- 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