• The Senior Consultant Engineer for Human Factors will lead human factors activities for development of Lilly’s drug delivery devices/systems within the Delivery Device Research and Development (DDR&D) area.
• The individual will collaborate with medical, marketing, engineering, quality, manufacturing and regulatory team members to understand and apply human-centered design methodologies through Usability assurance, determination of desired user profiles, development of user documentation, and development of training programs.
• The successful candidate will be responsible for independently leading the planning, execution and reporting of human factors engineering, user interface and industrial design studies across all device programs according to current regulations and guidelines within the medical device and bio-pharmaceutical industries.
• The Senior Consultant Engineer for Human Factors will be responsible to ensure that:
• Expert HF/ID input is provided to device development teams for establishing design requirements, packaging requirements, training requirements and use instructions.
• HF/ID expertise is applied to create and complete design validation activities and clinical studies in support of regulatory submissions.
• Human factors engineering concepts are incorporated early in the development process based on industry best practices.
• In addition, the Senior Consultant Engineer for Human Factors will act as a key advocate for these principles across Lilly.
• Human Factors is a key role supporting DDR&D’s mission to “Simplifying Patients Lives”. Specifically, the Senior Consultant Engineer for Human Factors is responsible for owning and maintaining the HF process, includes HF planning, requirements development, integration with risk management, user interface design verification, usability validation, and tech transfer requirements.
• The position requires excellent organizational, technical problem solving and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead external consultants.
• Develops protocols, study designs, plans and oversees study execution and vendor management for Device Design Validation activities, summative and formative human factor studies, and user preference studies.
• Essential Duties and Responsibilities include, but are not limited to, the following:
• Manages all usability and user preference studies from early to late stage of device development providing input to device design, ergonomics, and usability.
• Provides expert Human Factors input to device development and engineering groups based on usability and user preference study results.
• Prepares technical documents for use in the DHF and as input to regulatory filings.
• Human/System capabilities and limitations are properly reflected in the system requirements
• Human/System performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs)
• Human/System performance and safety risks are appropriately addressed in planning
• Determine the human factors cost, benefit, schedule, and performance baselines for candidate solutions
• Determine the human factors activities to be undertaken during the program, the schedule for conducting them, their relative priority, and the expected costs to be incurred.
• Work with senior management to align on organization, roles and responsibilities, and accountabilities to enable successful implementation of Human Factors objectives.
• Ensure that the right structure for accomplishing Human Factors goals is in place.
• Ensure that staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance.
• Actively coach and mentor talent in Human Factors across the organization.
Through metrics, monitoring and auditing, determine if external suppliers and other related functional areas (PSR&D and IDM) have appropriate processes and personnel in place to meet Human Factors standards and responsibilities.
DeviceSpace.com - 17 months ago
Eli Lilly and Company discovers, develops, manufactures and sells products in one business segment, pharmaceutical products. The Company...