Director, Manufacturing Engineering

Work Flexibility:
Onsite

Summary:

The Director, Manufacturing Engineering and Maintenance provides strategic and operational leadership for a large technical organization responsible for advancing manufacturing capability, asset reliability and operational performance across high-volume, highly automated regulated manufacturing operations. This role sets the engineering and maintenance strategy, directs capital portfolio execution, drives automation and reliability roadmaps, and partners cross-functionally to deliver sustained improvements in safety, quality, service, cost, compliance and productivity.

As a senior site leader, the Director builds organizational capability, develops technical talent and enables long-term business growth through disciplined execution, sound technical judgment and enterprise-level collaboration.

Essential Duties and Responsibilities:

Lead the Manufacturing Engineering and Maintenance organization (over 100 engineers, technicians and leaders) responsible for sustaining, improving and advancing high-volume, highly automated medical device assembly, packaging, pharmaceutical mixing and converting processes. Translate site and business objectives into engineering and maintenance strategies, long-term roadmaps, team priorities, measurable goals and individual performance objectives that improve safety, quality, service, cost, productivity and compliance. Lead prioritization, planning and execution of complex engineering projects, automation programs, equipment upgrades, capacity expansions, cost reduction initiatives and business growth projects, balancing long-term capability development with urgent operational support needs.

Manage $55M+ capital portfolio planning and execution, including business case development, project justification, budget adherence, resource allocation, risk management, vendor engagement and cross-functional stakeholder alignment. Provide technical leadership and decision-making support for manufacturing equipment, automation, controls, process performance, manufacturability, equipment reliability, asset lifecycle management and continuous improvement initiatives. Develop and improve maintenance strategy, asset reliability practices, preventive and predictive maintenance approaches, spare parts strategies and equipment lifecycle plans that reduce manufacturing loss, improve uptime and strengthen production continuity.

Partner with Operations, Maintenance, Quality, EHS, Supply Chain, Finance and other functions to identify and resolve manufacturing issues, mitigate technical and operational risk, improve operating performance and ensure engineering work complies with safety, GMP, quality, regulatory and company standards. Lead and coach teams through structured problem solving, root cause analysis and continuous improvement efforts that address systemic safety, quality, compliance, equipment reliability, productivity and business continuity issues.

Provide oversight for process FMEAs, control plans, change requests, SOPs, work instructions, manufacturing documentation, nonconformances, corrective and preventive actions, audit observations and other quality system deliverables where engineering ownership or support is required. Provide direction and coaching for equipment, process and cleaning validation strategies, protocols, execution, documentation and issue resolution in a regulated manufacturing environment. Establish and sustain engineering, automation, maintenance and documentation standards, best practices and governance processes that improve execution consistency and enable knowledge sharing across teams and sites.

Manage relationships and performance expectations with equipment suppliers, automation integrators, contractors and technical service providers supporting capital projects, operational support and specialized engineering work. Partner with Advanced Operations to support new product introductions, process transfers, and launch readiness.  Own capacity expansion and manufacturing scale-up activities by ensuring engineering, maintenance, validation, documentation and production support requirements are effectively planned and executed.

Plan organizational capacity, define capability needs, allocate internal and external engineering resources, and build, coach and develop a high-performing technical organization that supports current site needs, succession planning and future business growth. Communicate complex technical plans, project status, risks,…