Senior Project Manager

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.

• 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)

• 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

• 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