Sr Project Manager, Design Transfer & Advanced Manufacturing

Job Summary:

The Sr Project Manager, Design Transfer & Advanced Manufacturing will lead complex process development and manufacturing transfer initiatives for new product introductions (NPI) and improvements to operational efficiency. This role bridges product design and mass production, ensuring seamless integration of advanced manufacturing technologies, test systems, and assembly solutions across our global facilities.

Duties & Responsibilities:

• Lead cross-functional teams through design transfer from R&D to manufacturing.
• Coordinate cross functional development activities and dependencies to support DFM/DFA, Process, & Test Development.
• Coordinate cross functional deployment activities and dependencies to support transfer, setup, validation, and scale-up activities.
• Oversee design to deployment schedule of assembly fixtures, jigs, and tooling.
• Manage full project lifecycle from internal user requirements to production deployment and duplication of custom Automated systems.
• Manage Manufacturing Test solutions from risk coverage to design and production deployment.
• Develop, monitor, and report on project timelines, risk mitigation, and resource allocation.
• Collaborate with teams in global factories - travel required.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, and internal QMS.
• Support continuous improvement and lean manufacturing initiatives.
• Communicate project status to senior leadership and stakeholders.

Minimum Qualifications and Experience:

• 5+ years in product design, process engineering, or manufacturing transfer.
• Strong understanding of ICT/FCT, fixture design, and automation and test systems.
• Expertise with product development methodologies and processes.
• Excellent project management, communication, and cross-cultural collaboration skills.
• Excellent conceptual, analytical, and problem-solving abilities.
• Ability to excel in a fast-paced and dynamic work environment.

Preferred Qualifications and Experience:

• PMP certification preferred.
• Familiarity with electromechanical medical devices and Class II regulatory environments will be a plus.

Education:

BS or MS degree in Engineering or a related field.

Compensation: The anticipated range for this position is $120,000 - $150,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.