Design + Human Factors Engineering Senior Director

Lilly • Indianapolis, IN

32d

About The Position

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. Position Title: Design + Human Factors Engineering Senior Director –DDCS Department Name: Delivery, Device and Connected Solutions Purpose: In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. 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.

Requirements

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

Nice To Haves

• Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75)
• 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

Responsibilities

• 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 (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) Human performance and safety risks are appropriately addressed in planning.
• The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) 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
• 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.
• 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
• 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

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees