Project Leader

Ventura SolutionsChicago, IL
Onsite

About The Position

Our client is seeking an Assembly Project Leader that will be responsible for the successful delivery and implementation of a manual assembly line with a target annual capacity of 300,000 units. This role will lead end-to-end execution, including equipment delivery, installation, qualification, and production ramp-up, while serving as the primary interface between internal teams and external equipment suppliers (OEMs). The Assembly Project Leader is a hands-on, execution-focused role requiring strong experience in manufacturing line implementation, equipment integration, and cross-functional coordination.

Requirements

  • Bachelor’s degree in Engineering, Manufacturing, or a related technical field (or equivalent experience)
  • Proven experience leading manufacturing line implementation, equipment integration, or similar projects
  • Strong experience working with equipment OEMs and managing vendor deliverables
  • Hands-on experience with: Assembly processes (manual or semi-automated)
  • Hands-on experience with: Factory Acceptance Testing (FAT)
  • Hands-on experience with: Equipment installation and commissioning
  • Ability to read and interpret technical drawings, layouts, and process flows
  • Strong cross-functional communication and project coordination skills
  • Experience in medical device, pharmaceutical, or regulated manufacturing environments
  • Familiarity with controlled environments (cleanroom/white room)
  • Knowledge of validation and qualification processes (IQ/OQ/PQ)
  • Experience developing work instructions and process documentation
  • Understanding of error-proofing (poka-yoke) and process control strategies
  • Strong project execution and delivery focus
  • Excellent stakeholder communication and coordination
  • High attention to detail and process quality
  • Problem-solving and decision-making under timeline pressure
  • Ability to work effectively in a fast-paced, onsite environment

Responsibilities

  • Lead the delivery of a manual assembly line in compliance with user requirements specifications (URS)
  • Serve as the primary point of contact for the assembly equipment OEM, managing communication and deliverables
  • Coordinate with product development engineering and injection molding teams to manage design changes and iterations
  • Validate and confirm equipment layout and process flow within defined cleanroom/white room constraints
  • Support development and implementation of control strategies to minimize assembly errors and ensure process robustness
  • Develop clear, concise operator work instructions and standard operating procedures (SOPs)
  • Drive pre–Factory Acceptance Testing (FAT) readiness activities and ensure successful FAT execution
  • Oversee equipment delivery, installation, and commissioning at the receiving site
  • Coordinate qualification activities (IQ/OQ/PQ where applicable)
  • Support initial production ramp-up to meet capacity and performance targets
  • Ensure alignment across stakeholders and maintain progress toward key project milestones
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