Design + Human Factors Engineering Senior Director

Design + Human Factors Engineering Senior Director –DDCS

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 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.

The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company.

This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries.

Position Responsibilities

Design and Human Factors:

• Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio.
• Ensures that human capabilities and limitations are adequately reflected in the system requirements.
• Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives.
• Human performance and safety risks are appropriately addressed in planning.
• The staff is highly trained in Human Factors processes, relevant standards and FDA guidance.
• Human Factors Standards are appropriately documented in the Design Control Quality System.
• Project milestones are met by identifying and managing risks and escalating as appropriate.
• Functional budgets and project forecasts are maintained in compliance with P&L.

People:

• Responsible for developing and managing the Design + Human Factors Engineering team.
• Provides leadership, feedback, coaching, performance and career development support to direct reports.
• Ensures career development discussions, talent assessment, and succession planning are in place for employees.
• Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization.

Strategy / Corporate Integration:

• Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team.
• The delivery strategy and project workload are closely linked to that of the business units, sales affiliates, medical, manufacturing and marketing. The position would work closely with the above groups to consistently align the strategies and projects.
• Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry.

Relationship Management:

• Ensure compliance with external collaborations.
• Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units).
• Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve.

Minimum Requirements

Education:

• MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience.

Experience:

• Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products.
• Experience working within a sponsor organization.
• Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting.
• Human subjects research bioethics and study design.
• Prior supervisory experience of team organization.
• Ability to work effectively across boundaries.
• Demonstrated quality mindset, ability to influence and leadership capabilities.

Additional Skills and Preferences:

Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities. Business skills (capital and expense differentiation and impact on COGS and variance). Communication and interpersonal skills necessary for broad interactions at all levels of the corporation. Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.). Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners. Leadership skills with previous experience managing technical personnel and alliance partnerships. Demonstrated ability to lead cross-functional teams.

Additional Information

Position Location: Indianapolis, IN Ability to travel ~10-20% of the time, both domestic and international.

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