Senior Director, Embedded Systems & Process Engineering - Drug Delivery Devices & Combination Products

Lilly • Indianapolis, IN

4d • $163,500 - $239,800

About The Position

This is a rare opportunity to lead the engineering at the intersection of embedded systems, automation, and high-volume manufacturing for the devices that deliver Lilly’s medicines to patients. You will own how next-generation drug delivery devices and combination products are designed for assembly, automated at scale, and built right the first time across a global manufacturing network. If you are an engineering leader who is energized by assembly technologies, embedded electronics, and the challenge of making complex products manufacturable, this role offers the scope and the platform to shape it. 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

• Advanced degree (Master's degree or MBA with a Bachelor's degree) in Engineering (Electrical, Manufacturing, Automation, Mechanical or related discipline)
• 10+ years of experience in regulated industries.
• Proven ability to lead multidisciplinary engineering teams in a matrixed environment. Minimum 5 years experience leading teams.
• Strong working knowledge of product and process development in a regulated industry.
• Demonstrated success leading programs with embedded electronics/firmware.
• Demonstrated leadership in process engineering, process automation, or manufacturing engineering.
• Strong understanding of automated assembly systems, joining technologies and part handling solutions, and/or PLC-based control systems and industrial automation concepts.
• Working knowledge of engineering principles as applied to automated equipment.
• Strong communication and stakeholder-influence skills.

Nice To Haves

• Direct experience in medical devices, combination products, or other highly regulated manufacturing environments (e.g., FDA design controls, ISO 13485).
• Experience supporting global manufacturing networks and external automation suppliers.
• Experience in digital health, wireless systems, signal processing, or cloud-connected product ecosystems.

Responsibilities

• Serve as the functional leader for product embedded systems, assembly technologies, automation engineering, and assembly controls across DDCS, leading a multidisciplinary organization of engineering managers and senior technical leaders.
• Set DDCS strategy, in partnership with Manufacturing & Quality 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 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.
• 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, and error handling, fault recovery, and system diagnosability.
• Ensure assembly automation designs appropriately apply engineering principles, including: Sensor and actuator integration, signal integrity and noise considerations, and electrical safety and compliance.
• Partner with Manufacturing, Quality, Digital, and IT teams to ensure alignment on: Control system validation, data integrity and traceability, and 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 60601 and 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: Senior