Engineering Advisor-Human Factors
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
This position will lead human factors activities for the development of Lilly's drug delivery devices/systems within the Delivery, Device and Connected Solutions (DDCS) Research and Development area. This individual will be responsible for leading design, execution and reporting of human factors engineering methods and activities across all delivery system programs according to current regulations and appropriate guidelines within the medical device and bio-pharmaceutical industries.
The role requires the ability to collaborate effectively with cross-functional team leadership including 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 qualified candidate will have excellent organizational, technical problem solving, and communication skills (written and verbal). This individual will need to demonstrate the ability to lead teams, to influence cross functional partners, to adapt to a rapidly changing environment, and to effectively lead external consultants.
- Provides direction for development of protocols, study designs, plans and oversees study execution and vendor management, if applicable, for all human factors activities throughout the product development lifecycle including: heuristic evaluations, user research, exploratory concept development, and formative and summative human factor studies.
- Manages all usability and user research studies from early to late stage of device development providing input to delivery system design and development.
- Provides expert Human Factors input to engineering groups based on usability activity results and design principles.
- Conducts use related hazard analysis and facilitation of Failure Modes and Effects Analysis
- Prepares technical documents for usability files within the DHF and as input to regulatory submission.
- Potential to lead a team of 2-5 experts in usability/ human factors
- Partners with Human Factors Project Managers to help ensure technical oversight of planning and execution of internal and vendor-based usability studies
- Partners with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors Ensures that:
- User capabilities and limitations and their associated use-related risks are appropriately addressed in planning, requirements development, and risk management.
- 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
- MS or PhD in Human Factors / Usability Engineering or related field with 3+ years' experience
- Experience working in a regulated environment (e.g. Medical, DOD, DOT, etc.)
- Extensive experience (8+ 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 development 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
- 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 statu