Acceptance Testing, Assembly Equipment, Assembly Line, Biotech and Pharmaceutical, Change Management, Cleanroom, Commissioning, Communication Skills, Consulting, Cross-Functional, Delivery Management, Detail Oriented, Documentation, Injection Molding, Leadership, Manufacturing, Medical Equipment, OEM (Original Equipment Manufacturer), Organizational Skills, Problem Solving Skills, Process Control Engineering, Process Flow, Process Quality, Process Validation, Product Development, Product Engineering, Production Support, Project Execution, Project/Program Coordination, Proofreading, Regulatory Compliance, Standard Operating Procedures (SOP), Statement of Work (SOW), Technical Drawing, Vendor/Supplier Management
LOCATION
Chicago, IL
POSTED
17 days ago
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)
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.