Senior Director, Embedded Systems & Process Engineering (ESPE)

Eli Lilly and Company • Indianapolis, IN

1d • Onsite

About The Position

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 proven ability to lead multidisciplinary teams in a matrixed environment.
• 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 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.
• 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
• Experience working within medical devices, combination products, or other highly regulated manufacturing environments.
• Experience supporting global manufacturing networks and external automation suppliers.
• Working knowledge of electrical engineering principles as applied to automated equipment.
• Experience in digital health, wireless systems, signal processing, or cloud‑connected device ecosystems.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director