Senior Human Factors Engineer-Delivery and Device
About the Position
Are you experienced in leading 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? Do you seek opportunities to collaborate with medical, marketing, engineering, quality, manufacturing and regulatory team members to apply human-centered design methodologies? If so, we have the role for you.
We are seeking a Senior Human Factors Engineer to lead human factors activities for development of Lilly’s drug delivery devices/systems within the Delivery Device and Connected Solutions (DDCS) area.
This position requires 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 lead external consultants.
Responsibilities you can expect in this role include:
- Provides direction for development of protocols, study designs, plans and oversees study execution and vendor management, if applicable, for all human factors activities including: summative and formative human factor studies, heuristic evaluations and user research
- Drive customer and patient-focused product innovation by leading the human factors engineering processes within the organization, including the execution of 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.
- Lead 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.
- Lead 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 development 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.
- Advance the development of the Human Factors engineering team by acting as a mentor and leader for less experienced Human Factors engineers.
- Manages all usability and user research studies from early to late stage of device development providing input to device and packaging design and development.
- Provides expert 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.
- Contribute to recruitment and development of a team of 6-10 scientists including experts in usability/ human factors.
- Partner with Human Factors Project Managers to help ensure technical oversight of planning and execution of internal and vendor-based usability studies.
- Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors.
It is also important you ensure the following:
- 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 alternatives
- Compliance to relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance is adequately addressed in Human Factors processes and deliverables
- MS in engineering or related sciences with specialization in Human Factors / Usability Engineering in the Medical or Pharmaceutical industry
- 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 (IEC 62366, ANSI/AAMI HE75) and FDA guidance
- 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
- Estimated travel (domestic and international) is approximately 25% per year
- Location: Indianapolis, IN LTC-N
- Experience with regulatory agencies interactions and / or regulatory submissions of delivery devices and combination products
- 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
About Eli Lilly and Company
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.
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.