Lilly Human Factors Group Leader in Cambridge, Massachusetts
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 35,000 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.
In 1992, Lilly established the Delivery, Device, and Connected Solutions (DDCS) business for the purpose of creating, developing, launching and refining proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units.
Are you a highly inclusive leader? Do you relentlessly and passionately pursue breakthrough solutions for patients? We are seeking a highly experienced and motivated Human Factors leader to join our DDCS team. You will be a key leader in collaborating effectively with cross-functional teams 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.
Key Responsibilities :
Provide 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.
Lead a team of 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.
Ensures that performance characteristics and their associated benefits and risks assist in deciding among design alternatives
Bachelor's degree in Human Factors / Usability Engineering or related field with 10+ years’ experience OR PhD in Human Factors / Usability Engineering or related field with 3+ years’ experience
Experience working in a regulated environment
Understanding of and experience with relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and FDA guidances
Additional Skills and Preferences:
Extensive experience (10+ 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
Demonstrated ability to work effectively across boundaries and influence to drive organizational culture change
Excellent written and verbal communication skills
Demonstrated quality mindset, ability to influence and leadership capabilities
Demonstrated ability to lead cross-functional teams
- Position Location: Indianapolis, IN or Cambridge, MA
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!