Design + Human Factors Engineering Senior Director

Role Summary

Design + Human Factors Engineering Senior Director leads the Design and Human Factors organization within Delivery, Device and Connected Solutions (DDCS), providing strategic direction and execution for design and human factors activities across medical devices, combination products, and packaging. The role supports product innovation and development, ensuring human factors considerations are integrated into system requirements, risk management, and regulatory alignment. It reports on program milestones, budgets, and P&L impact while building a high-performing, cross-functional team.

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; assess human performance characteristics, costs, benefits, and risks in decision-making; address human performance and safety risks in planning.
• Maintain staff training in Human Factors processes, relevant 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.

Responsibilities (Continued)

• People: Develop and manage the Design + Human Factors Engineering team; provide leadership, coaching, performance and career development support; conduct career development discussions, talent assessment, and succession planning; execute long-range recruiting strategy and technical succession planning.

Responsibilities (Strategy / Corporate Integration)

• Execute Delivery and Device Strategy in collaboration with management, aligning with Business Units, Sales Affiliates, Medical, Manufacturing, and Marketing.
• Partner with Regulatory to advance human factors leadership and help draft policy positions across Lilly and the industry.

Responsibilities (Relationship Management)

• Ensure compliance with external collaborations; maintain effective relationships with Lilly partners external to DDCS (Quality, Manufacturing, Regulatory, Digital Health, Business Units); manage external vendors and collaborations to support evolving 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, ability to influence and leadership capabilities.

Qualifications (Preferred)

• 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: Excellent communication and interpersonal skills for broad interactions at all levels of the corporation.
• Preferred: Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.).
• Preferred: Experience managing suppliers and alliance partners in a diverse, networked technical organization; leadership of cross-functional teams.

Skills

• Leadership and people management
• Cross-functional collaboration and influence across regulatory, quality, manufacturing, and commercial teams
• Regulatory knowledge related to medical devices and combination products
• Design and human factors engineering across complex product portfolios
• Risk management and design control processes

Additional Requirements

• Position Location: Indianapolis, IN
• Travel: Ability to travel approximately 10‚Äì20% of the time, domestically and internationally