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. 50274BR
Internal Number: 50274
About Eli Lilly & Company
Company Overview 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 worldwide 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.