Design + Human Factors Engineering Senior Director

Role Summary

Senior Director of Design + Human Factors Engineering for Delivery, Device and Connected Solutions (DDCS) at Lilly. Provides strategic direction, execution, and reporting of design and human factors activities across medical devices, combination products, and packaging, ensuring compliance with current regulations and guidelines. Leads a top-tier engineering and science organization and partners across regulatory, quality, manufacturing, and business units to drive product innovation and development.

Responsibilities

• Lead and grow a top-tier engineering and science organization with expertise in design and human factors engineering applied across the portfolio.
• Ensure that human capabilities and limitations are reflected in system requirements; manage human performance risks, lifecycle costs, and safety planning.
• Maintain staff training in Human Factors processes, standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance; document Human Factors Standards in the Design Control Quality System.
• Meet project milestones by identifying and managing risks and escalating as appropriate; maintain functional budgets and project forecasts in compliance with P&L.
• Develop and manage the Design + Human Factors Engineering team; provide leadership, coaching, performance development, and succession planning; implement long-range recruiting and technical succession planning.
• Execute a Delivery and Device Strategy in collaboration with management; align strategies with Business Units, Sales, Medical, Manufacturing, and Marketing.
• Partner with Regulatory to lead in human factors policy and positions across Lilly and the industry.
• Maintain relationships and alignment with internal partners and external vendors; manage external collaborations to support development strategies.

Qualifications

• Required: MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience.
• Required: Experience with regulatory agency interactions and/or regulatory submissions of delivery devices and combination products.
• Required: Experience working within a Sponsor organization.
• Required: Working knowledge of HF regulatory requirements, protocols, IRBs, usability studies and reporting.
• Required: Human subjects research bioethics and study design.
• Required: Prior supervisory experience of team organization.
• Required: Ability to work effectively across boundaries; demonstrated quality mindset, influence, and leadership capabilities.
• Preferred: Understanding of device/drug regulations, standards and guidances (e.g., CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75).
• Preferred: Business skills related to capital/expense differentiation and impact on COGS and variance.
• Preferred: Strong communication and interpersonal skills for broad interactions; broad technical knowledge of system/design engineering, product development, and commercialization (device, container closure, packaging).
• Preferred: Experience leading cross-functional teams and managing suppliers/alliance partners.
• Preferred: Leadership experience managing technical personnel and alliance partnerships; ability to lead cross-functional teams.

Additional Requirements

• Position Location: Indianapolis, IN
• Travel: Ability to travel ~10-20% of the time, domestically and internationally