Project Leader
On-site · Chicago, Illinois, United States or Bartlett, Illinois, United States
Job Summary
Lead the delivery of a manual assembly line from URS to FAT readiness; serve as primary point of contact with the assembly equipment OEM; coordinate with product development engineering and injection molding teams to manage design changes; validate equipment layout and process flow within cleanroom constraints; support control strategy development to minimize errors; develop operator work instructions and SOPs; drive FAT readiness and oversee equipment delivery, installation, and commissioning; coordinate IQ/OQ/PQ activities and support initial production ramp-up; ensure alignment across stakeholders and progress toward milestones in Bartlett and Chicago onsite environments.
Required 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
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