Senior Project Manager

Sterling Engineering; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

Sterling Engineering is seeking a Senior Project Manager for a long-term contract to lead delivery of a high-speed assembly line for a regulated medical device environment. The role is hands-on and serves as the primary interface between the OEM, product development, and manufacturing teams to ensure design, build, and launch of a new automated system.

You will drive end-to-end deployment from concept through FAT, coordinate with engineering, operations, and external machine builders, and ensure

Qualifications

• Proven experience delivering OEM equipment or capital equipment builds in regulated environments.
• Strong background in assembly automation or medical device manufacturing.
• Experience with FAT, IQ/OQ/PQ validation activities.
• Ability to coordinate across engineering, operations, and external machine builders.

Responsibilities

• Lead end-to-end delivery of a new assembly system from design through production ramp-up.
• Serve as primary liaison with the selected OEM machine builder.
• Manage alignment with URS (User Requirement Specifications) throughout the project lifecycle.
• Coordinate design iterations with product development engineering and injection molding teams.
• Validate equipment layout and process flow within controlled environment constraints.
• Support development of control strategy to reduce assembly errors and improve reliability.
• Develop clear operator work instructions and assembly procedures.
• Drive pre-FAT readiness activities and ensure successful Factory Acceptance Testing (FAT).

Skills

Project management

OEM coordination

Regulated manufacturing

Cross-functional leadership

Cost/time management

Tools

FAT/IQ/OQ/PQ

Job description

We are seeking a Senior Project Manager for a long-term contract assignment supporting the delivery of a high-speed manual assembly line for a regulated medical device manufacturing environment.

This role is highly hands-on and serves as the primary interface between the OEM, product development, and manufacturing teams to ensure successful design, build, and launch of a new automated assembly system.

Key Responsibilities

• Lead end-to-end delivery of a new assembly system from design through production ramp-up
• Serve as primary liaison with the selected OEM machine builder
• Manage alignment with URS (User Requirement Specifications) throughout the project lifecycle
• Coordinate design iterations with product development engineering and injection molding teams
• Validate equipment layout and process flow within controlled environment constraints
• Support development of control strategy to reduce assembly errors and improve reliability
• Develop clear operator work instructions and assembly procedures
• Drive pre-FAT readiness activities and ensure successful Factory Acceptance Testing (FAT)

Required Experience

• Proven experience managing OEM equipment or capital equipment builds
• Strong background in assembly automation or medical device manufacturing environments
• Experience with FAT, installation, commissioning, and qualification activities (IQ/OQ/PQ)
• Ability to coordinate across engineering, operations, and external machine builders
• Strong understanding of regulated manufacturing environments (medical device or pharma preferred)
• Comfortable working onsite at OEM and manufacturing facilities as required

Why This Role

• Lead a critical new equipment launch from concept through production
• Direct interface with OEM, engineering, and manufacturing leadership teams
• High-impact program in a regulated medical device environment
• Long-term engagement with strong technical ownership