Senior Director, Embedded Systems & Process Engineering (ESPE)

Eli Lilly and Company • Indianapolis, IN

19h

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. Organization and Position Overview: The Delivery, Device, and Connected Solutions (DDCS) organization supports the design, development, and commercialization of drug products and pharmaceutical delivery systems, including medical devices, combination products, and container closure systems. The Senior Director, Embedded Systems and Process Engineering (ESPE) provides functional and strategic leadership for device embedded systems (as applicable), manufacturing technologies, automated assembly processes, and global automation and control strategies supporting DDCS products from development through commercialization. This role is accountable for defining, deploying, and governing embedded systems design (for those products with that capability), joining technologies, automated assembly architectures (including process data capture/reporting), part handling systems, and assembly control strategies that enable scalable, compliant, and robust manufacturing across Lilly’s global network and external partners. The ESPE leader ensures that assembly solutions are designed for embedded control (as applicable), manufacturability, automation readiness, safety, and regulatory compliance, while advancing DDCS capabilities in standardization and automation maturity.

Requirements

• Bachelor's degree in Engineering (Mechanical, Electrical, Manufacturing, Automation) or related discipline with 10+ years experience in a regulated industry.
• 5+ years of experience leading teams.
• Strong working knowledge of device development processes and medical device regulations/standards.
• Demonstrated success leading programs with embedded electronics/firmware.
• Demonstrated leadership in assembly process engineering, automation engineering, or manufacturing engineering.
• Strong understanding of one or more of these concepts: Automated assembly systems Joining technologies and part handling solutions PLC‑based control systems and industrial automation concepts Working knowledge of electrical engineering principles as applied to automated equipment.
• Proven ability to lead multidisciplinary engineering teams in a matrixed environment.
• Strong communication and stakeholder‑influence skills.

Nice To Haves

• Advanced degree (MS, MBA, PhD) in Engineering (Mechanical, Electrical, Manufacturing, Automation) or relevant field with 5+ years experience in a regulated industry..
• Experience working within medical devices, combination products, or other highly regulated manufacturing environments.
• Experience supporting global manufacturing networks and external automation suppliers.
• Experience in digital health, wireless systems, signal processing, or cloud‑connected device ecosystems.

Responsibilities

• Leadership & Organizational Development Serve as the functional leader and subject‑matter authority for product embedded systems, assembly technologies, automation engineering, and assembly controls across DDCS.
• Set DDCS strategy, in partnership with M&Q for capabilities in: Embedded systems requirements, architecture, design, verification, and technology roadmaps.
• Joining technologies (e.g., adhesive bonding, ultrasonic welding, laser welding, snap‑fit and mechanical joining) Automated and semi‑automated assembly processes Part feeding and handling systems (e.g., feeder bowls, pick‑and‑place, conveyors, escapements) Assembly automation architectures and control strategies
• Lead, coach, and develop engineering managers and senior technical leaders within ESPE.
• Foster a culture of quality, safety, technical rigor, and continuous improvement, aligned with DDCS and Lilly leadership expectations.
• Assembly Technology & Process Strategy Define and govern preferred assembly and joining technologies for DDCS devices, including: Technology selection criteria Design guidelines and limitations Process development and qualification approaches
• Establish standards for: Assembly process development and validation Tooling, fixturing, and automation equipment requirements Robustness, repeatability, and failure recovery
• Drive early integration of Design for Assembly (DFA) and Design for Manufacturability (DFM) principles into device development programs.
• Balance near‑term program execution with long‑term investments in reusable assembly platforms and standardized automation solutions.
• Embedded Systems (ES) Oversight Provide ES strategic inputs to DDCS portfolio decisions across commercial, innovation, and multi‑molecule efforts.
• Ensure ES contributions to DDCS programs are appropriately‑resourced, technically sound, risk‑managed, and prioritized.
• Provide technical oversight and direction for embedded electronics, firmware development, system integration, modeling, and ES verification activities.
• Ensure ES delivers compliant, high‑quality work product including requirements, system architecture, modeling artifacts, and verification traceability.
• Automation, Controls & Electrical Engineering Oversight Provide leadership and governance for automation and control strategies used in DDCS assembly systems.
• Establish expectations and standards related to: PLC‑based control architectures Safety circuits, interlocks, and fail‑safe design Human‑machine interfaces (HMIs) and operator interaction Error handling, fault recovery, and system diagnosability
• Ensure assembly automation designs appropriately apply electrical engineering principles, including: Power distribution and grounding Sensor and actuator integration Signal integrity and noise considerations Electrical safety and compliance
• Partner with Manufacturing, Quality, Digital, and IT teams to ensure alignment on: Control system validation Data integrity and traceability Cybersecurity and access control expectations (as applicable)
• Ensure automation and control strategies are scalable and transferable across internal sites and external manufacturing partners.
• Program Execution & Operational Oversight Provide technical oversight for ESPE contributions to DDCS development and commercialization programs.
• Ensure delivery of compliant, high‑quality assembly engineering work products, including: Assembly process definitions and specifications Equipment and automation requirements Process FMEAs, risk assessments, and project-specific CQV documentation
• Allocate ESPE resources to meet program commitments while maintaining organizational health and sustainability.
• Support resolution of technical issues related to: Assembly yield and throughput Automation reliability and downtime Joining quality and process variability
• External Partner & Supplier Engagement Oversee ESPE engagement with external embedded system design and development firms, automation suppliers, system integrators, and manufacturing partners.
• Ensure external solutions align with Lilly design controls, quality agreements, and engineering standards.
• Provide technical governance for outsourced embedded system development, assembly process and automation development, including review of control strategies and equipment designs.
• Quality & Regulatory Leadership Model a proactive quality mindset, ensuring assembly technologies and automation systems are designed to minimize risk and variability.
• Ensure compliance with applicable regulations and standards, including: Design controls (21 CFR 820.30) ISO 13485 and ISO 14971 IEC 60601and IEC 62304 Applicable equipment, software, and validation requirements
• Ensure risks associated with assembly processes, automation, and controls are identified early, documented, and mitigated.

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
• 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