Eli Lilly and Company · 2 weeks ago
Design + Human Factors Engineering Senior Director
Indianapolis, IN
Full-time
Onsite
Lead/Staff, Director/Executive
$164K/yr - $264K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Design + Human Factors Engineering Senior Director will provide leadership and strategic direction for product innovation and development in delivery and device systems, ensuring compliance with regulations and fostering collaboration across various departments.
BiotechnologyHealth CareMedicalPharmaceutical
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
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
Qualification
Required
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
Preferred
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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