Job Description

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.

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

Qualifications

• 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)
• Factory Acceptance Testing (FAT)
• 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

Locations

• Bartlett, IL and Chicago, IL

Employee Type

• W2
• Contract position: length about 10 months

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp-to-permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled